According to a medical device recall issued in february by the fda. Biomet claims first with shoulder system orthopedics. Read online surgical technique zimmer biomet book pdf free download link book now. The implants are designed to create a new, smoothly functioning joint that can prevent painful boneonbone contact. In december 2016, zimmer biomet issued an fsn informing clinicians of the higher than anticipated rate of fracture of titanium comprehensive reverse. Comprehensive total shoulder system surgical technique. Zimmer biomet offers surgeons knee replacement solutions, with a comprehensive suite of orthopaedic knee implant products and instruments. On september 4, 20, biomet orthopedics, llc, announced the first clinical use in the u. Jul 30, 2019 zimmer biomet offers surgeons knee replacement solutions, with a comprehensive suite of orthopaedic knee implant products and instruments. Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due. The zimmer biomet shoulder recall affects implants distributed between october 2008 and september 2015, which could have been used in implants up to the date of the recall. Zimmer biomet shoulder replacement recall commercial.
In both cases, the patient did not comply with the warnings in. Extend involved shoulder over the edge of the table so the arm can be brought into full extension and adduction. Instead of improving arm movement, however, the implant caused several problems and, on december 20, 2016. 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. The fda recently issued a class i recall for the zimmer biomet comprehensive reverse shoulder system humeral tray model 115340. Zimmer biomet recalled certain biomet comprehensive reverse shoulder humeral trays in december 2016 due to the devices having a higher than anticipated fracture rate. Clinical outcomes and complications of cementless reverse total. Zimmer biomet reverse shoulder recall lawsuit lawyer. Zimmer biomet is being sued because its reverse shoulder implant has been failing at a rate higher than the company initially revealed. Zimmer comprehensive reverse total shoulder system zimmer biomet. Zimmer biomet recall of comprehensive reverse shoulder. For product information, including indications, contraindications, warnings, precautions and potential adverse effects, see the package insert and biomets website. The comprehensive fracture, and revision and micro. In addition to those specified above, the proximal.
Those with rotator cuff tears or severe shoulder arthritis were some of the intended patients for this device. Comprehensive fracture system preoperative planning evaluate xrays of both the fractured shoulder and the contralateral shoulder. Ischs opinionsincluding as to biomets regulatory compliance and the adequacy of biomets design, manufacturing, and distribution of the comprehensive reverse shoulder systemwould. Zimmer biomet shoulder lawsuits consumer safety watch. Victims of such fractures may be entitled to file a zimmer biomet shoulder replacement lawsuit to obtain compensation for damages incurred as a result of their injury. Humeral traytaper failure in modular reverse total shoulder. Comprehensive nano stemless shoulder zimmer biomet. In addition to those specified above, the proximal shoulder replacement prostheses are indicated for use in oncology applications, complex humeral fractures and revisions. Biomet manufactures a variety of shoulder joint replacement prostheses intended for partial or total shoulder joint arthroplasty for use in cemented and uncemented biological.
The biomet comprehensive reverse total shoulder system. Zimmer biomet is recalling the comprehensive reverse shoulder because these devices are fracturing at a higher rate than is stated in the labeling. Zimmer biomet comprehensive shoulder implant lawsuit claims. Biomet shoulder replacement class action lawsuit biomet. 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.
Fractured devices can require painful removal surgery, as well as infection, permanent loss of shoulder function, or death. Biomet has received two complaints of this problem. These results support the surface cement technique with a modular gritblasted titanium surface and cruciform stem during primary tka. Shoulder joint replacement components include humeral stems, humeral heads, and glenoid components.
Product liability lawsuits are currently being filed against zimmerbiomet alleging that the comprehensive reverse shoulder systems failed. The fda this week released information on a class 1 recall of zimmer biomets nyse. Anyone who underwent shoulder replacement or implant surgery from 2008 through december of 2016 and received a zimmer biomet implant should learn if their device is included. Zimmer biomet recalls comprehensive reverse shoulder due.
Class 3 device recall biomet comprehensive shoulder system. Comprehensive total shoulder system figure 12 figure set the correct version using the amount of external rotation of the forearm, slide the resection guide against the humerus and finger tighten the thumb screw. Comprehensive reverse shoulder system zimmer biomet. For product information, including indications, contraindications, warnings, precautions and potential adverse effects, see the package insert and biomet s website.
The choice of implant was comprehensive reverse shoulder system biomet inc. Jul 12, 2016 comprehensive reverse shoulder system. Biomet comprehensive reverse shoulder products are intended for total. Mar 02, 2019 zimmer biomet offers surgeons knee replacement solutions, with a comprehensive suite of orthopaedic knee implant products and instruments. Zimmer biomet, the medical device manufacturer of the comprehensive reverse shoulder system previously had to recall other reverse shoulder devices used in surgeries because of product defects. Shoulder, elbow, and wrist replacement implants use metal alloys and polyethylene plastic to restore motion and reduce or eliminate pain.
Approximately 55 percent of all shoulder replacements are the result of complex fractures of the proximal humerus. In both cases, the patient did not comply with the warnings in the package insert. The comprehensive shoulder stems fracture, primary. Comprehensive shoulder system, 4 mm, 122 mm long, primary shoulder stem, ti6al4v, standard length porous plasma. As a result of the failure, additional surgery is needed to remove and replace the allegedly defective devices.
The arcos platform comprehensive solutions that simplify the complex. Surgical technique zimmer biomet pdf book manual free. The position of the resection guide boom on the reamer shaft, along with the calibrated reaming depth and stem choice, are directly related. Zimmer biomet comprehensive reverse shoulder system is being recalled because of high fracture rate on february 16, 2017, the u.
The comprehensive total shoulder system is an evolutionary design based on the successful clinical heritage of the biomodular shoulder system. This site is like a library, you could find million book here by using search box in the header. In september 2010, biomet recalled about 45 of the comprehensive reverse shoulders due to fractures between the trunnion and baseplate. 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 upper part of the operating table has to be open on the homolateral side to allow shoulder extension shoulder table. The zimmer biomet comprehensive reverse shoulder system is a surgicallyimplanted artificial shoulder device used to help restore arm movement in patients with rotator cuff tears who have developed a severe type of shoulder arthritis called arthropathy, and for whom traditional shoulder replacement is not an option. 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. Associated component involved comprehensive shoulder stem b 4. The science and art of medical care is to provide the right. Mar 08, 2017 the fda recently issued a class i recall for the zimmer biomet comprehensive reverse shoulder system humeral tray model 115340. Zimmer biomet recalls comprehensive reverse shoulder due to a. Comprehensive segmental revision total and reverse. The cause of the bending fatigue could not be determined.
Radiographs were evaluated by one of the authors according to the knee society total knee arthroplasty roentgenographic evaluation and scoring system 27 for radiolucent zones, femoral component flexion and valgus, tibial component slope and kne, and anatomic axis was measured on the longstanding film for overall mechanical alignment. Biomet comprehensive shoulder implant lawsuit claims. Zimmer biomet shoulder replacement lawsuit for fracture. Zimmer biomet reverse shoulder lawsuits what you must know. Total shoulder system is an evolutionary design based on the successful clinical heritage of the biomodular. Over 1 million times per year, biomet helps one surgeon. 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.
The thumb screw on the resection boom is not captured. Zimmer biomet comprehensive reverse shoulder implant. Shortly after zimmer biomet announced the recall of certain comprehensive reverse shoulder humeral trays in late 2016, attorneys around the country began airing tv commercial to ensure that affected patients were aware of their important legal rights. The comprehensive reverse shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due. Titanium glenospheres are intended for patients with cobalt alloy material sensitivity. 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. Zimmer biomet reverse shoulder lawsuit lawyer settlements. Biomet comprehensive reverse shoulder products are indicated for use in patients whose shoulder. Biomet, as a manufacturer of this device, does not practice. Zbh comprehensive reverse shoulder system over issues with the devices fracturing. Fda class i recall issued for zimmer biomet reverse. The baseplate and modular bicortical central screw allow the utilization of the best bone available within the glenoid. Utilizing innovative technologies, the system is able to allow for surgeon efficiency through. Keeping your shoulder and elbow level, slowly raise your hand until it is in line with your head.
These options provide intraoperative flexibility, even in complex revision cases. Determine amount of comminution and proximal bone loss on xray andor ct scans. Accuracy of patientspecific instrumentation in shoulder arthroplasty. With the baseplate in position, the versadialglenosphere allows the ability to select both the amount and direction of offset. Ensure both xrays are at the same degree of external rotation. Request pdf the biomet comprehensive reverse total shoulder system design considerations and surgical techniques the biomet comprehensive reverse shoulder arthroplasty rsa is newer. Zimmer biomet has announced a recall for certain comprehensive reverse shoulder products due to a higherthan expected risk of fracture. Fda class i recall issued for zimmer biomet reverse shoulder. Product liability lawsuits are currently being filed against zimmer biomet alleging that the comprehensive reverse shoulder systems failed. Set the correct version using the amount of external rotation of the forearm, slide the resection.
Zimmer biomet has issued three recalls of the comprehensive reverse shoulder implant, due to risks of fracture or defective locking rings. Sixty patients 65 knees died prior to a fiveyear followup and had not undergone revision tka at the last followup. 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. 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. Hcp content posted july 12, 2016 in animated demonstrations and zimmer biomet extremities. Zimmer biomet marketed its medical device as a way to help restore a patients natural arm movement, especially individuals who had suffered a rotator cuff tear known as cuff tear arthropathy a severe type of shoulder arthritis, and who failed to. The zimmer biomet comprehensive reverse shoulder is a device that is surgically implanted to help patients restore arm movement. Biomet comprehensive reverse shoulder arthroplasty rsa is the result of the combination of the biomet comprehensive shoulder system. The comprehensive shoulder system shoulder education. Comprehensive reverse shoulder system zimmer biomet tv.
All books are in clear copy here, and all files are secure so dont worry about it. Plaintiff also argues that biomet was required to tender a complete expert report pursuant to fed. The comprehensive shoulder system was developed in conjunction with david dines, m. Yom firms zimmer biomet environmentally controlled room specifications standard operating procedme, sop 9. 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. If you or a loved one had problems after shoulder replacement surgery, you should contact our law firm immediately. The versadial humeral head prosthesis is intended for use only with the comprehensive humeral fracture stem and the glenoid components of the biomodular shoulder system. 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. Aug 25, 2008 zimmer biomet is recalling the comprehensive reverse shoulder because these devices are fracturing at a higher rate than is stated in the labeling.
The implant is designed to enable surgeons to repair broken bone while replacing the damaged shoulder joint. 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 srs system is compatible with comprehensive shoulder. The comprehensive humeral fracture stem is intended for use with the biomodular humeral heads and glenoid components. 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. The latest generation of biomet comprehensive reverse shoulder system biomet, warsaw, indiana is. Five patients with a total of six humeral traytaper failures were identified from 300 patients with.
67 543 1217 652 333 1144 1190 1551 954 568 1469 160 1608 1027 501 1037 507 354 1196 42 1603 949 611 611 100 1053 1616 1367 905 234 1569 550 1241 945 1534 113 844 702 282 364 445 351 930 1172 277 961