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Recall of Certain Zimmer Biomet Polyethylene Joint Components Distributed 12-16 to 2-17Feb. 27, 2017
Weitz & Luxenberg is accepting cases from people injured by certain Zimmer Biomet polyethylene joint implants. The company recalled specific lots of its devices after discovering the potential presence of elevated endotoxin levels.
The company sent out an Urgent Medical Device Recall (Removal) to risk managers and surgeons on February 17, 2017. The field action affected components used in several of the company’s hip, knee, and shoulder implants. Zimmer Biomet did not recommend any additional patient monitoring instructions related to the field action for surgeons beyond their existing follow-up protocols.
Potential Risks from Elevated Endotoxins
Zimmer Biomet’s notice said Zimmer does not anticipate endotoxins to pose immediate health risks to patients, but long-term consequences from exposure or use of the potentially affected devices may result in inflammatory conditions or adverse tissue reactions. In the company’s anticipated “worst case” scenario, endotoxin exposure may result in aseptic loosening – the failure of the bond between the implant and bone without infection – or the need for revision surgery.
Endotoxins are found inside bacterial cells and can be released when the cells disintegrate. Zimmer Biomet discovered elevated levels of endotoxins in several samples of its polyethylene implants during routine bacterial endotoxin testing (BET).
During a six-week period, Zimmer Biomet found three polyethylene implant samples that exceeded the U.S. Food and Drug Administration’s (FDA) adopted standard for endotoxin levels in devices, 20 endotoxin units (EU) per device, and decided to remove from distribution all polyethylene implants manufactured during the relevant time period. The affected implants were distributed between December 2016 and February 2017.
Zimmer Biomet’s removal notice includes 13 pages listing hundreds of affected items with specific lot and item numbers, representing a wide variety of components in its polyethylene implants. The company said in its notice it had yet to receive any complaints related to the issue.
Weitz & Luxenberg is interested in talking to patients who developed complications after receiving a Zimmer Biomet shoulder, hip, or knee implant from December 2016 to February 2017, affected by this recall.
If you or your loved one required revision surgery due to infection, adverse tissue reactions, inflammatory conditions, or aseptic loosening after receiving one of these affected implants, or if you are being treated for any of these or other related symptoms, you may be able to seek legal compensation for your injuries.
Weitz & Luxenberg is a national leader in medical device litigation and can review your legal options. Fill out our contact form on this page or call us at (800) 476-6070 for a free consultation.
- Zimmer Biomet. (2017, February 17). Urgent Medical Device Recall (Removal) – Lot Specific.
- Cedars-Sinai. (n.d.). Aseptic Loosening. Retrieved from https://www.cedars-sinai.edu/Patients/Programs-and-Services/Imaging-Center/For-Physicians/Musculoskeletal-Radiology/Exhibits-and-Presentations/Knee-Arthroplasty/Aseptic-Loosening.aspx