Zimmer biomet offers a complete array of shoulder replacement systems and associated products. Use an elastic stretch band of comfortable resistance. 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. Step 5 insertion of the positioning sleeve utilize the proper sized inserter for the chosen. Tip squeeze your shoulder blades together as you pull. The system uses innovative technologies to allow intraoperative flexibility, unmatched humeral stem options, and infinite humeral head offset possibilities. Zimmer biomet comprehensive shoulder implant lawsuit claims. It is not to be redistributed, duplicated or disclosed without the expressed written consent of biomet. 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.
Product liability lawsuits are currently being filed against zimmer biomet alleging that the comprehensive reverse shoulder systems failed. Zimmer biomet recalls comprehensive reverse shoulder due to a. Zimmer biomet shoulder replacement lawsuit for fracture. The comprehensive reverse shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. Determine amount of comminution and proximal bone loss on xray andor ct scans.
This biomodular shoulder surgical technique is utilized by david m. The comprehensive reverse shoulder story the goal was simple. Refer to attachment 2 affected product list for the affected itemslot combinations. Recognizing the limitations of other reverse shoulders, innovation was engineered into each component of the comprehensive reverse shoulder system. Comprehensive vault reconstruction system zimmer biomet. Reverse shoulder replacement lawsuits recall information. 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. Victims of such fractures may be entitled to file a zimmer biomet shoulder replacement lawsuit to. Zimmer biomet comprehensive reverse shoulder system is being recalled because of high fracture rate. In december 2016, zimmer biomet recalled 3,662 reverse shoulder components of its comprehensive model line. Apr 04, 2017 in december 2016, zimmer biomet issued an fsn informing clinicians of the higher than anticipated rate of fracture of titanium comprehensive reverse shoulder humeral trays manufactured prior to.
Utilizing innovative technologies, the system is able to allow for surgeon efficiency through. Generating an epub file may take a long time, please be patient. Each surgeon is responsible for determining the appropriate device and technique to utilize on each individual patient. Utilizing innovative technologies, the system is able to allow for surgeon efficiency through intraoperative. Shoulder joint metalpolymer semiconstrained cemented. Jul 12, 2016 comprehensive reverse shoulder system.
The comprehensive shoulder system zimmer biomet summit surgical. Request pdf the biomet comprehensive reverse total shoulder system design considerations and surgical techniques the biomet comprehensive reverse shoulder arthroplasty rsa is newer. Associated component involved comprehensive shoulder stem b 4. The bipolar humeral head is marketed for use in primary cases of noninflammatory degenerative joint disease, rheumatoid arthritis, correction of severe functional. Infraspinatus and teres minor you should feel this exercise at the back of your shoulder and into your upper back equipment needed. Zimmer biomet recalled more than 3600 reverse shoulder implants that could fracture. All trademarks herein are the property of biomet, inc. The comprehensive srs system is compatible with comprehensive shoulder. Comprehensive reverse shoder sstem indications biomet comprehensive reverse shoulder products are indicated for. Super eas heads medialization with retained contact surface on the glenoid total humerus coupler. Comprehensive total shoulder system intramedullary resection guide place the resection guide boom onto the reamer shaft to the below described locations depending on stem selection. Zimmer biomet comprehensive reverse shoulder implant.
In shoulder arthroplasty, there is a trend for shorter humeral implants to. Zimmer biomet comprehensive reverse shoulder recall. Zimmer biomet comprehensive reverse shoulder replacement fracture. Zimmer biomet recalled certain biomet comprehensive reverse shoulder humeral trays in december 2016 due to the devices having a higher than anticipated fracture rate. Patients harmed by biomets comprehensive reverse shoulder system may be able to seek compensation for medical expenses, wages lost and other damages in the form of a biomet comprehensive lawsuit. Titanium glenospheres are intended for patients with cobalt alloy material sensitivity. Biomet comprehensive shoulder implant lawsuit claims. Format for traditional and abbreviated 510ks, issued on august 12, 2005.
The biomet comprehensive reverse shoulder arthroplasty rsa is newer designed thirdgeneration reverse prosthesis. The latest generation of biomet comprehensive reverse shoulder system biomet, warsaw, indiana is. In addition, the biomet comprehensive shoulder is based upon the concept of an. Shoulder joint replacement components include humeral stems, humeral heads, and glenoid components. 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. It was one of the largest recalls of reverse shoulder devices in recent years. On september 4, 20, biomet orthopedics, llc, announced the first clinical use in the u. Biomet has received two complaints of this problem. Jul 06, 2017 a zimmer biomet shoulder replacement class action lawsuit is an option for those who may been harmed by a recalled comprehensive reverse shoulder. The comprehensive srs system is compatible with comprehensive shoulder components, comprehensive reverse shoulder components, the biomodular shoulder system and the discovery elbow, making it a unique solution to complex cases. 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. Biomet comprehensive reverse shoulder products are indicated for use in patients whose shoulder.
Comprehensive reverse shoulder system zimmer biomet. Zimmer biomet reverse shoulder recall lawsuit lawyer. Comprehensive shoulder system, 4 mm, 122 mm long, primary shoulder stem, ti6al4v, standard length porous plasma. According to a medical device recall issued in february by the fda. Ensure both xrays are at the same degree of external rotation. Class 3 device recall biomet comprehensive shoulder system. The investigator will be responsible for retaining, hardcopy, source documents for their. As a result of the failure, additional surgery is needed to remove and replace the allegedly defective devices. Zimmer biomet shoulder replacement class action for. The comprehensive reverse shoulder system was born from a desire to provide a complete shoulder arthroplasty solution to surgeons, without compromise. Zbh comprehensive reverse shoulder system over issues with the devices fracturing. The comprehensive shoulder system was developed in conjunction with david dines, m.
Zimmer biomet is recalling the comprehensive reverse shoulder because these devices are fracturing at a higher rate than is stated in the labeling. In the recall notice, zimmer biomet said its comprehensive reverse shoulder. A shoulder replacement fracture usually requires revision surgery, which can lead to permanent disability and other adverse health consequences. While these joints are among the least likely to develop conditions requiring joint replacement, there are implants that can reduce or eliminate pain and restore motion. The comprehensive segmental revision system srs utilizes a multioption approach to address proximal, distal and total humeral replacement with the convenience of an allinclusive system.
Increased sales of comprehensive total shoulder system received several fda 510k clearances including sidus stemfree shoulder and comprehensive augmented baseplate extremities comprehensive total shoulder system strong sales of the ncb plating system portfolio steady demand for the zimmer natural nail. The recall affects more than 3,600 devices in specific lots that were manufactured before september 2011 and distributed between october 2008 and september 2015. Screw the version control rod into the appropriate version. Zimmer biomet s comprehensive total shoulder system design is based on the successful clinical heritage of the biomodular shoulder system. Zimmer biomet recall of comprehensive reverse shoulder. The implant is designed to enable surgeons to repair broken bone while replacing the damaged shoulder joint. For example, right should be visible for a right shoulder.
Aug 25, 2008 class 1 recall issued for the zimmer biomet comprehensive reverse shoulder recalled by the fda due to serious device fractures. Comprehensive reverse titanium shoulder tray specific lots. Comprehensive fracture system preoperative planning evaluate xrays of both the fractured shoulder and the contralateral shoulder. Biomet, as the manufacturer of this device, does not practice medicine and does not recommend this device or technique. The word replacement makes one think that surgeons remove the entire joint. Fda 2017 zimmer biomet recalls comprehensive reverse. As well as being optimized for each patients unique anatomy, all of our shoulder systems address key surgeon needs so that joint reconstruction, range of motion, and kinetics may be restored, helping the patient get back to the activities of. These options provide intraoperative flexibility, even in complex revision cases. Request pdf the biomet comprehensive reverse total shoulder system. Humeral traytaper failure in modular reverse total shoulder. Zimmer biomet has recalled certain comprehensive reverse shoulder components due to a high rate of fracture.
Stemless shoulder arthroplasty systems with uncemented metaphyseal. 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 zimmer biomet comprehensive reverse shoulder is a device that is surgically implanted to help patients restore arm movement. The comprehensive reverse shoulder system was designed to provide a complete, seamless system based on the comprehensive shoulder platform. The upper extremities include the wrist, elbow, and shoulder. This material is intended for the biomet sales force and physicians only and is not intended for patient distribution. The cause of the bending fatigue could not be determined. The biomet comprehensive reverse total shoulder system. The comprehensive reverse shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to.
Positioning sleeve selection select the proper sized positioning sleeve based on the size of the tap used in step 3. The comprehensive total shoulder system is an evolutionary design based on the successful clinical heritage of the biomodular shoulder system. In both cases, the patient did not comply with the warnings in the package insert. Comprehensive reverse shoulder system the comprehensive reverse shoulder builds on the foundation of the comprehensive shoulder system. Hcp content posted july 12, 2016 in animated demonstrations and zimmer biomet extremities. A zimmer biomet shoulder replacement lawsuit is an option for. In the recall notice, zimmer biomet said its comprehensive reverse shoulder system humeral tray model 115340 suffered a high fracture rate. Now, this spirit of innovation lives on through evolved solutions for challenging cases, including comprehensive vault reconstruction system vrs. Mar 08, 2017 the fda recently issued a class i recall for the zimmer biomet comprehensive reverse shoulder system humeral tray model 115340. The position of the resection guide boom on the reamer shaft, along with the calibrated reaming depth and stem choice, are directly related to the proper. Biomet claims first with shoulder system orthopedics this week. Patientreported outcome after stemmed versus stemless total. The fda this week released information on a class 1 recall of zimmer biomets nyse.
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