Approximately 55 percent of all shoulder replacements are the result of complex fractures of the proximal humerus. Aug 25, 2008 class 1 recall issued for the zimmer biomet comprehensive reverse shoulder recalled by the fda due to serious device fractures. Comprehensive total shoulder system surgical technique. Biomet comprehensive reverse shoulder products are indicated for use in patients whose shoulder. Biomet comprehensive shoulder implant lawsuit claims.
Request pdf the biomet comprehensive reverse total shoulder system. The versadial humeral head prosthesis is intended for use only with the comprehensive shoulder stems. Biomet has received two complaints of this problem. Zimmer biomet is recalling the comprehensive reverse shoulder because these devices are fracturing at a higher rate than is stated in the labeling. The fact that zimmer biomet had its comprehensive reverse shoulder approved without any human testing likely comes as a shocking surprise to many recipients of the device. 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. Determine amount of comminution and proximal bone loss on xray andor ct scans. The fda this week released information on a class 1 recall of zimmer biomets nyse. Zimmer biomet shoulder replacement class action for. Orthopaedic automatic hip templating with the merge orthotemplates and imagesnap technology, merge healthcare introduces. The zimmer biomet comprehensive reverse shoulder is a device that is surgically implanted to help patients restore arm movement. In both cases, the patient did not comply with the warnings in the package insert. In december 2016, zimmer biomet issued an urgent medical device safety warning pdf about the risk of fractures with comprehensive reverse shoulder replacements made before. 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.
Use an elastic stretch band of comfortable resistance. Dec 17, 2016 at least one of these shoulder implant lawsuits has reached a resolution. Zimmer biomet reverse shoulder lawsuit lawyer settlements. Hcp content posted july 12, 2016 in animated demonstrations and zimmer biomet extremities. Why was this shoulder replacement implant recalled. Make a longitudinal incision through the tendinous portion of the subscapularis muscle and capsule, just medial to the lesser tuberosity figure 3. 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. In cases of severe contracture, subscapularis lengthening. Reversed total shoulder arthroplasty is a popular treatment in rotator cuff arthropathy. Infraspinatus and teres minor you should feel this exercise at the back of your shoulder and into your upper back equipment needed. Utilizing innovative technologies, the system is able to allow for surgeon efficiency through intraoperative. The system uses innovative technologies to allow intraoperative flexibility, unmatched humeral stem options, and infinite humeral head offset possibilities.
The agency designated the zimmer biomet shoulder replacement recall class i, which indicates that the affected devices could cause serious injury or death. 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. Zimmer biomet comprehensive reverse shoulder system is being recalled because of high fracture rate. In todays business context mergers and acquisitions another common move. I had to solve a similar problem and what i ended up doing was creating a small pdfmerge utility that uses the pdfsharp project which is essentially mit licensed the code is dead simple, i needed a cmdline utility so i have more code dedicated to parsing the arguments than i do for the pdf merging. Associated component involved comprehensive shoulder stem b 4.
The biomet comprehensive reverse shoulder arthroplasty rsa is newer. Zimmer biomet announces fda clearance of the comprehensive. Zimmer biomet s comprehensive total shoulder system design is based on the successful clinical heritage of the biomodular shoulder system. 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. Zimmer biomet recall of comprehensive reverse shoulder. Zimmer biomet reverse shoulder recall lawsuit lawyer. Zimmer biomet devices pose fracture risk shoulder implant. Cementless surface replacement arthroplasty of the shoulder. 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 humeral positioning sleeves are for cemented use only and are intended for use with the comprehensive fracture stem. Zimmer biomet shoulder lawsuit, infection, death, revision.
Comprehensive reverse shoulder system the comprehensive reverse shoulder builds on the foundation of the comprehensive shoulder system. Zimmer biomet recalls comprehensive reverse shoulder replacement. Zimmer biomet shoulder replacement recall for comprehensive. Tip squeeze your shoulder blades together as you pull. This was accomplished by combining the baseplate and modular central screw with biomets exclusive versadial glenosphere. Request pdf the biomet comprehensive reverse total shoulder system design considerations and surgical techniques the biomet comprehensive reverse shoulder arthroplasty rsa is newer. The biomet comprehensive reverse total shoulder system.
Customers were asked to complete the attached response form and return it along with recalled product to 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. Class 3 device recall biomet comprehensive shoulder system. The anatomical shoulder cemented, uncemented pressfit, fracture and revision humeral stems are compatible with the ashcom shoulder acconnector and the comprehensive reverse trays and bearings. 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. Comprehensive total shoulder system figure 3 patient positioning and incision identify anterior structures and externally rotate the humerus. The comprehensive reverse shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to. Comprehensive reverse shoulder system zimmer biomet.
Zimmer biomets comprehensive reverse shoulder humeral implant is being recalled due to a risk of the shoulder implant fracturing and resulting in the need for revision surgery to remove or replace the failed device. Biomet sent an urgent medical device recall notice letter dated april 29, 2015 to affected customers via fedex. The implant is designed to enable surgeons to repair broken bone while replacing the damaged shoulder joint. The comprehensive shoulder system zimmer biomet summit surgical. In february of 2016, biomet agreed to settle a case, filed in a denver federal court, in which a patient claimed that he had suffered implant fractures with two separate comprehensive reverse shoulder devices. According to a medical device recall issued in february by the fda. In the recall notice, zimmer biomet said its comprehensive reverse shoulder system. Mar 03, 2017 if you have a comprehensive reverse shoulder implant, these are the three steps that you should take. For product information, including indications, contraindications, warnings, precautions and potential adverse effects, see the package insert and biomets website. Positioning sleeve selection select the proper sized positioning sleeve based on the size of the tap used in step 3.
Biomet comprehensive srsdiscovery elbow ulna components. The comprehensive shoulder stems fracture, primary and revision are intended for use with the biomodular humeral heads and glenoid components and versadial humeral heads. Zimmer biomet reverse shoulder lawsuits what you must know. Ensure both xrays are at the same degree of external rotation. Zimmer biomet comprehensive shoulder implant lawsuit claims. Three steps that all patients of the zimmer biomet. Reverse shoulder replacement lawsuits recall information.
Zimmer biomet comprehensive reverse shoulder implant. Comprehensive reverse shoder sstem indications biomet comprehensive reverse shoulder products are indicated for. The comprehensive segmental revision system offers modular. Comprehensive reverse shoulder system zimmer biomet tv. Each surgeon is responsible for determining the appropriate device and technique to utilize on each individual patient. 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. Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to. Biomet as a manufacturer of this device does not practice medicine and does not recommend this device or. Utilizing innovative technologies, the system is able to allow for surgeon efficiency through. As a result of the failure, additional surgery is needed to remove and replace the allegedly defective devices. Step 5 insertion of the positioning sleeve utilize the proper sized inserter for the chosen. Product liability lawsuits are currently being filed against zimmer biomet alleging that the comprehensive reverse shoulder systems failed.
In addition to those specified above, the proximal shoulder replacement prostheses are indicated for use in oncology applications, complex humeral fractures and revisions. 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 08, 2017 the fda recently issued a class i recall for the zimmer biomet comprehensive reverse shoulder system humeral tray model 115340. After you calibrate your image and select a merge healthcare implant overlay, the application automatically scales the im plant overlay to the true image size based on the image calibration. Titanium glenospheres are intended for patients with cobalt alloy material sensitivity. The zimmer biomet reverse shoulder received fda approval in 2008 through the controversial 510k premarket approval process, which allows manufacturers to bring products to market if they can show the products are substantially similar to an existing product already being sold and distributed. Comprehensive fracture system preoperative planning evaluate xrays of both the fractured shoulder and the contralateral shoulder. On september 4, 20, biomet orthopedics, llc, announced the first clinical use in the u. 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 letter identifed the affected product, problem and actions to be taken. Zbh comprehensive reverse shoulder system over issues with the devices fracturing. Court records from the us district court of colorado show that.
The comprehensive shoulder system was developed in conjunction with david dines, m. In addition, the biomet comprehensive shoulder is based upon the concept of an. The cause of the bending fatigue could not be determined. Comprehensive segmental revision system zimmer biomet. Biomet claims first with shoulder system orthopedics this week. This biomodular shoulder surgical technique is utilized by david m. Biomet, as the manufacturer of this device, does not practice medicine and does not recommend this device or technique. Jul 12, 2016 comprehensive reverse shoulder system. The comprehensive total shoulder system is an evolutionary design based on the successful clinical heritage of the biomodular shoulder system. In september 2010, biomet recalled about 45 of the comprehensive reverse shoulders due to fractures between the trunnion and baseplate.
139 856 1549 565 394 1007 1609 856 78 311 1234 1377 1221 380 638 650 1045 466 1387 138 433 715 200 1274 1214 729 169 381 672 92 563 1244 1130 611 212 936 111 1421 1233