Zimmer prosthetics recently announced that a process monitoring failure led to higher than expected amounts of manufacturing residues left on the Zimmer M/L Taper hip replacements, specifically those models with Kinectiv Technology Femoral Stems and Necks. These residues can cause serious adverse health issues including allergic reactions, pain, infections, or death. Use of these products may require the need for a painful revision surgery to replace the affected implant. The hip prostheses which were manufactured and distributed between March 31, 2015 through April 20, 2015 are suspected of the highest degree of contamination, although the full extent of the damage has yet to be assessed.
The Zimmer M/L Taper with Kinectiv Technology Femoral Stems and Necks are Titanium alloy implants used for hip replacements that allow the surgeon to fit the implant specifically to the patient. During hip replacement surgery, the damaged portions of the hip joint are removed and replaced with an integrated system of products, which includes the femoral stem and neck. These implants represent a marked improvement over past models of hip replacement, and generally require a shorter and less invasive surgery for installation. However, in March of 2015, technicians at the Zimmer manufacturing center alerted Zimmer that its products had become exposed to certain manufacturing residues, and due to failures in their final preparation processes, some of these residues may not have been removed. In response, Zimmer initiated a full recall on June 8, 2015 of the affected prostheses.
If you or a loved one has recently had a hip replacement, and Zimmer products were used, it may be a good idea to contact the Zimmer customer call center at 1-877-946-2761 between 8:00 am and 5:00pm EST with any questions or concerns.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program. The online reporting website for the FDA is: www.fda.gov/MedWatch/report. On the FDA’s MedWatch website, patients can download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178. It is important for patients to do this so that the FDA, the agency responsible for ensuring the quality of American medicines, can collect sufficient data to make informed decisions on how to deal with this problem and how best to prevent similar ones in the future. To read the MedWatch safety alert, including a link to the Class I Recall notice, follow the link at: http://www.fda.gov/Safety/MedWatch/
If you or a loved one has recently had a Zimmer hip replacement, and have experienced any adverse side effects, including the need for painful revision surgery, the attorneys at the Ruth Law Team encourage you to contact an attorney to discuss your legal rights. Learn more about various hip replacement recalls and the hip cases we are currently investigating. We can be reached by phone at 1-888-783-8378 24/7.