Our innovations help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. The shoulder is a highly mobile joint that is also inherently unstable to allow for range of motion. The zimmer biomet comprehensive reverse shoulder humeral tray model 115340 was supposed to help patients regain mobility often loss from rotator cuff injuries, arthritis induced arthropathy, or a previously failed shoulder joint replacement. Mini stem technique intramedullary resection guide assembly place the. According to a medical device recall issued in february by the fda.
Food and drug administration fda issued a public notice saying it had started the most serious type of medical device recall for the biomet comprehensive reverse shoulder system humeral tray model 11530. The sidus stemfree shoulder system zimmer biomet is a modular assembly. The head includes a metal substrate having a coupling taper and a polymeric cover mounted to the metal substrate having a convex outer surface and a generally planar base. For product information, including indications, contraindications, warnings, precautions and potential adverse effects, see the package insert and biomets website. The randomization sequence will be computergenerated by block randomization four in each block and balanced according to age in years 1849, 5059, 60. The biomet comprehensive reverse shoulder arthroplasty rsa is newer. Approximately 55 percent of all shoulder replacements are the result of complex fractures of the proximal humerus. The comprehensive reverse shoulder system is a design produced by biomet.
Comprehensive reverse shoulder system zimmer biomet. At biomet, we strive to view our work through the eyes of. Class 3 device recall biomet comprehensive shoulder system. Comprehensive reverse shoder sstem indications biomet comprehensive reverse shoulder products are indicated for. Reverse shoulder arthroplasty rsa is offered to young patients with a failed previous arthroplasty or a cuffdeficient shoulder, but the overall results are still uncertain. Us product portfolio for small bone and joint orthopedic devices 2017 medfolio.
Comprehensive fracture system preoperative planning evaluate xrays of both the fractured shoulder and the contralateral shoulder. Priority attention is the hallmark of our service commitment, and we stand ready to offer you an unprecedented level of service and personalized solutions, including. Screw the version control rod into the appropriate version. The zimmer biomet comprehensive reverse shoulder is a device that is surgically implanted to help patients restore arm movement. The lectures have been compressed, for ease of download.
Fda class i recall issued for zimmer biomet reverse shoulder. On september 4, 20, biomet orthopedics, llc, announced the first clinical use in the u. Zimmer biomet s comprehensive total shoulder system design is based on the successful clinical heritage of the biomodular shoulder system. A class 1 recall of zimmer biomets comprehensive reverse shoulder system has been announced by the u.
Functional outcomes of modular conversion of hemiarthroplasty or. Biomet has received two complaints of this problem. If you have a comprehensive reverse shoulder implant, these are the three steps that you should take. The biomet total toe system utilizing the koenig score. Biomet comprehensive reverse shoulder products are indicated for use in patients whose shoulder. Anatomic total shoulder arthroplasty tsa is a surgical procedure that can relieve pain. Recall for zimmer biomet shoulder replacement device.
Zimmer biomet comprehensive reverse shoulder implant. Us product portfolio for small bone and joint orthopedic. The remaining components used with the glenoid component of the comprehensive shoulder system will allow for proximal or total. Volume 35, issue 1, januaryfebruary 1996, pages 2326. A quantitative analysis of the effect of baseplate and.
The simpliciti by wright medical and the sidus system by zimmer biomet are the only. Zimmer biomet reverse shoulder recall lawyers osteen. In addition to those specified above, the proximal. On the other hand, tobacco use negatively impacts the outcomes following rtsa by nearly doubling the overall complication rate. Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect gtin global trade identification number codes. Radiographic measurements including femoral and tibial coronal and sagittal alignment, as well as overall anatomic valgus angle hip knee ankle angle. In addition, the biomet comprehensive shoulder is based upon the concept of. Clinical outcomes and complications of cementless reverse. Reverse shoulder arthroplasty rsa has been shown to be effective at treating pain and restoring mobility in patients with cuff tear arthropathy cta. Infraspinatus and teres minor you should feel this exercise at the back of your shoulder and into your upper back equipment needed. On the right shoulder, patient had a revision to a large head hemiarthroplasty and on the left shoulder. Biomet sent an urgent medical device recall notice letter dated april 29, 2015 to affected customers via fedex. In both cases, the patient did not comply with the warnings in the package insert. Mar 08, 2017 the fda recently issued a class i recall for the zimmer biomet comprehensive reverse shoulder system humeral tray model 115340.
Common clinical challenges such as scapular notching, a more demanding patient population and polyethylene wear were inputs of the original design rationale, and comprehensive. Shoulder arthroplasty for chondrolysis sciencedirect. Request pdf the biomet comprehensive reverse total shoulder system. However, the device has proven to be dangerous and the fda initiated a recall for the devices high rate of fracture and risk of death to patients. The comprehensive total shoulder system is an evolutionary design based on the successful clinical heritage of the biomodular shoulder system. Zimmer offers personalized knee replacement systems that focus on the unique needs of patient, surgeon and institution.
Laurent beguin saintetienne denis bouttens berck sur mer charles cohn nice geert declercq anvers jean grimberg paris dominique huguet nantes eric lesprit bordeaux pierre massart chambery bruno rio nancy jacques teissier montpellier. The biomet comprehensive reverse total shoulder system design considerations and surgical techniques. American shoulder and elbow surgeons score improved from 34. Our purposes were to determine whether psi significantly improves implantation accuracy during total shoulder arthroplasty tsa and to analyze available techniques and. Tx, usa, b tornier reverse shoulder prosthesis tornier inc, stafford, tx, usa, c biomet comprehensive reverse total shoulder replacement biomet inc, warsaw, in, usa. It has a proven 112 clinical history, and combines materials that have been tested to withstand the demands of joint arthroplasty.
Pdf scapular notching is a common complication after reverse shoulder arthroplasty and has been. The science and art of medical care is to provide the right. Zbh comprehensive reverse shoulder system over issues with the devices fracturing. At zimmer biomet, our innovations help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. The agency designated the zimmer biomet shoulder replacement recall class i, which indicates that the affected devices could cause serious injury or death. Zimmer biomet recall of comprehensive reverse shoulder. The cause of the bending fatigue could not be determined. Comprehensive reverse shoulder system superior approach this brochure is presented to demonstrate the surgical technique and postoperative care protocol utilized by david adkison, m. It is not to be redistributed, duplicated or disclosed without the express written consent of biomet. Our gender solutions compensate for important differences between mens and.
Determine amount of comminution and proximal bone loss on xray andor ct scans. For more information or to see if you are a candidate for this device for painful shoulder arthritis, please schedule an appointment with dr. Us market report for shoulder reconstruction device 2017. Ensure both xrays are at the same degree of external rotation. As understood, attainment does not recommend that you have extraordinary points.
However, clinical data are lacking to support the increased time and expense associated with psi. Comprehensive total shoulder system anatomic engineering, surgeon versatility and ease of use the comprehensive total shoulder system is an evolutionary design based on the successful clinical heritage of the biomodular shoulder system. Stemless shoulder arthroplasty has numerous theoretical advantages, including. Fractures may result in revision surgeries which could cause serious adverse health consequences such as permanent loss of shoulder function, infection, or rarely, death. The biomet comprehensive reverse total shoulder system.
Comprehensive total shoulder system surgical technique. Upper extremity orthopaedic trauma association ota. Class i recall high fracture rate posted 02162017 audience. Reverse shoulder arthroplasty in patients aged 65 years or.
Knee replacement products knee, hip, shoulder, spine. Pdf total shoulder arthroplasty utilizing ministem humeral. Shoulder arthroplasty is a surgical procedure, which assists in the treatment of severe pain and stiffness in people suffering from various forms of arthritis or degenerative joint disease of the. For zimmer biomet sales representatives, you can log in to access more information 3d preoperative planning and intraoperative instrument guides to assist surgeons in the precise alignment of knee implants, tailored to the patients unique anatomy.
Step 5 insertion of the positioning sleeve utilize the proper sized inserter for the chosen. Backed by more than 30 years of clinical history, coonradmorrey total elbow is the elbow replacement system of choice. Zimmer biomet for his development of its comprehensive shoulder arthroplasty system, which relates directly to this article. The comprehensive fracture system templates are then placed over the contralateral shoulder and the proper stem size is selected. Comprehensive reverse shoulder system augmented baseplate. Comprehensive reverse shoulder system augmented baseplate surgical technique. A second nurse also attempted an iv start with the same lot number of product. Zimmer biomet shoulder replacement recall for comprehensive. Annotations api oai service bulk downloads developers forum. Reverse shoulder arthroplasty can therefore be read either from start to finish. Accuracy of patientspecific instrumentation in shoulder.
Comprehensive reverse shoulder system the comprehensive reverse shoulder builds on the foundation of the comprehensive shoulder system. Acromial fractures in reverse shoulder arthroplasty. February 11, 2017the fda announced a class 1 recall of the zimmer biomet comprehensive reverse shoulder implant model 115340 based on information that the device is associated with a higher than expected failure rate. This material is intended for the biomet sales force and physicians only and is not intended for patient distribution. Positioning sleeve selection select the proper sized positioning sleeve based on the size of the tap used in step 3. The system uses innovative technologies to allow intraoperative flexibility, unmatched humeral stem options, and infinite humeral head offset possibilities. Comprehensive inclusion and exclusion criteria created homogeneity within the. A nurse attempted to insert a catheter and the patient complained of extreme pain at attempt so the nurse stopped.
Pdf inferior glenosphere placement reduces scapular notching. There has been significant recent emphasis on the use of patientspecific instrumentation psi in shoulder arthroplasty. Zimmer biomet recalls comprehensive reverse shoulder due to a. The components were implanted according to the manufacturers specifications biomet comprehensive shoulder system, warsaw, in. Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to. The company says this is the only device of its type that features a patentpending dual trajectory, allowing surgeons to elect a reverse or total shoulder procedure intraoperatively. Using the selected stem size, note the previously drawn line and the hashmark to which it corresponds. Aug 25, 2008 class 1 recall issued for the zimmer biomet comprehensive reverse shoulder recalled by the fda due to serious device fractures. Reverse total shoulder arthroplasty rtsa is a treatment option for patients with severe osteoarthritis, rotator cuff arthropathy, or massive rotator cuff tear with pseudoparalysis. Biomet claims first with shoulder system orthopedics this week. Reverse shoulder arthroplasty biomechanics, clinical techniques. Reverse shoulder arthroplasty springer for research. This joint is anchored by muscular attachment to the spine in the back and to the sternum breastbone through the clavicle collarbone. Zimmer biomet announces fda clearance of the comprehensive.
Safety alerts for human medical products comprehensive. Fda provides update on recall of zimmer biomet shoulder implant the fda has provided additional information to patients and medical providers regarding the recall of the comprehensive reverse shoulder implant initiated by zimmer biomet. Comprehensive total shoulder system figure 4 standard, mini, and micro stem technique figure 5 figure 6 humeral preparation using the 4, 5 or 6 mm starter reamer and ratcheting thandle, bore a pilot hole through the humeral head along the axis of the humeral shaft, just lateral to the heads articular surface and just medial to the rotator. Mar 02, 2019 postoperative radiographs demonstrate the radiographic appearance of surface cementing technique in figure 6. Alongside some of the worlds top healthcare professionals, we help deliver new possibilities to patients. All procedures were performed by the senior surgeons using the biomet reverse comprehensive shoulder system warsaw, indiana. Revision to reverse total shoulder arthroplasty restores.
Delayed axillary artery occlusion after reverse total. This study aimed to assess pain relief, function, and survivorship of shoulder arthroplasty for chondrolysis and to assess risk factors for failure. Biomet as a manufacturer of this device does not practice medicine and does not recommend this device or technique. The first comprehensive book devoted exclusively to reverse shoulder. A shoulder implant assembly including a humeral stem, a head, a cup, and a taper adaptor.
Management of failed metalbacked glenoid component in. Now fda approved arizona institute for sports, knees and. Additional notes and information are provided by many authors in the meeting notes section of. Request pdf the biomet comprehensive reverse total shoulder system design considerations and surgical techniques the biomet comprehensive reverse shoulder arthroplasty rsa is newer. A multicenter, prospective 2year analysis of the sidus stemfree. We describe a case of delayed axillary artery occlusion after reverse total shoulder arthroplasty. The humeral stem is configured to be inserted into a humerus bone.
Why was this shoulder replacement implant recalled. The advent of modular shoulder arthroplasty systems. He has written over 300 articles, 7 text books,numerous chapters and given over presentations both nationally and internationally. For example, right should be visible for a right shoulder. Current designs and trends in reverse shoulder arthroplasty. The benefits of the vanguard revision knee system include zimmer biomet offers surgeons knee replacement solutions, with a comprehensive suite of orthopaedic knee implant products and instruments. Bailie is now fda approved and being implanted worldwide. Biomet maxim knee pdf vanguard cruciate retaining cr knee design features. The versadial humeral head prosthesis is intended for use only with the comprehensive shoulder stems. The comprehensive reverse shoulder has been trusted since 2008. Zimmer biomet comprehensive shoulder implant lawsuit claims.
We are to deduce not only the early functional outcomes and complications of cementless rtsa during the learning curve period but also complicationbased, and operation timebased learning curve of rtsa. Biomet comprehensive reverse shoulder products are indicated for. Zimmer biomet is recalling the comprehensive reverse shoulder because these devices are. Over 1 million times per year, biomet helps one surgeon provide personalized care to one patient. Reverse shoulder arthroplasty biomechanics, clinical. Specialized product expertise case planning assistance stepbystep procedural guidance treatment warranty product ordering and shipment tracking we realize. The fda this week released information on a class 1 recall of zimmer biomets nyse. Axillary artery injury has been associated with shoulder dislocation and surgery. Zimmer biomet is recalling the comprehensive reverse shoulder because these devices are fracturing at a higher rate than is stated in the labeling.
It also makes conversion of an anatomic shoulder arthroplasty or fracture hemiarthroplasty ha to rsa much easier. Use an elastic stretch band of comfortable resistance. At zimmer biomet dental, our focus is always on you. Zimmer biomet reverse shoulder lawsuits what you must know.
Three steps that all patients of the zimmer biomet. The cup has a concave surface configured to articulate with the. The comprehensive shoulder stems fracture, primary and revision are intended for use with glenoid components and versadial humeral heads of the. Designed for primary and revision intervention as well as posttraumatic and rheumatoid arthritis, this elbow implant provides comprehensive patientmatching flexibility and simple, precise instrumentation. Responsibility mark frankle, scott marberry, derek pupello, editors. Patientreported outcome after stemmed versus stemless. Oct 22, 2016 biomet comprehensive reverse shoulder arthroplasty rsa is the result of the combination of the biomet comprehensive shoulder system, based upon a humeral stem component platform, with the different specific parts of the reverse ballandsocket design. Tip squeeze your shoulder blades together as you pull. The specific implant subject to the recall is the zimmer biomet comprehensive reverse shoulder system humeral tray model 115340 manufactured between august 2008 and september 2011, and distributed between october 2008 and september 2015. He is codeveloper of many shoulder implant systems created in conjunction with zimmer and biomet and including the comprehensive shoulder system. Reverse shoulder system prosthesis was used zimmer.
Comprehensive reverse titanium shoulder tray specific lots. The comprehensive reverse shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to. Zimmer biomet comprehensive reverse shoulder system is being recalled because of high fracture rate. Shoulder arthroplasty may be considered for endstage chondrolysis, but concerns exist about implant survivorship, given the younger age of this population. It is designed for use as a primary reverse prosthesis, or to convert to a reverse from a wellfxed comprehensive primary, revision or fracture stem. Shoulder arthroplasty market key attractions 20172023. The book begins with a history of rsa followed by a thorough overview of the basic science and biomechanics of the shoulder. Hcp content posted july 12, 2016 in animated demonstrations and zimmer biomet extremities.
Pdf subscapularis in reverse total shoulder arthroplasty. Novel solution for massive glenoid defects in shoulder. Effect of tranexamic acid on hematologic values and blood. The nano stemless total shoulder, codeveloped by dr. Current outcomes following reverse total shoulder arthroplasty. This is just one of the solutions for you to be successful. Associated component involved comprehensive shoulder stem b 4. For zimmer biomet sales representatives, you can log in to access more information.
Class 1 device recall biomet comprehensive reverse shoulder humeral figure 3 83. In addition to those specified above, the proximal shoulder replacement prostheses are indicated for use in oncology applications, complex humeral fractures and revisions. The injury was confirmed by doppler and angiography and was treated with angioplasty and stenting. Zimmer biomet reverse shoulder lawsuit lawyer settlements. To view power point presentations for download, click here. Focusing exclusively on reverse shoulder arthroplasty rsa techniques and devices, this plentifully illustrated text covers all aspects of this important and innovative treatment for shoulder pain and dysfunction. Patient underwent revision arthroplasty to a custom reverse prosthesis component biomet comprehensive custom reverse prosthesis, warsaw, in in 2008. Comprehensive reverse shoulder system zimmer biomet tv.