Defective Hip Replacement Parts Recalled By Zimmer
A relatively new implant used for hip replacements manufactured by Zimmer is the subject of a voluntary “Class I recall” asreported last month by the U.S. Food and Drug Administration (FDA). Zimmer issued the recall notice because it found “a process monitoring failure that lead to higher than expected amounts of manufacturing residue left on the devices.” A Class I recall is the most serious type of recall issued by the FDA as it means there is a reasonable probability that use of the defective product “will cause serious adverse health consequences or death.” In this instance, Zimmer’s finding that an excessively high manufacturing residue was being left on the devices means that following hip replacement surgery, the metal residue on the implant components will leak out into the patient’s body and likely cause infection, allergic reactions, pain or other serious side effects. It is, therefore, probable that anyone who received this recalled hip implant as part of his or her hip replacement surgery will now need revision surgery to remove and replace the defectively manufactured device.
If you or someone you know has had hip replacement surgery this year and you think it is possible the surgeon used the Zimmer® M/L Tapers with Kinectiv Technology System, call the law firm of Abramowitz, Pomerantz, and Morehead for a free evaluation of your case and discussion of your legal options with a Fort Lauderdale Products Liability Lawyer.
Based on information released by Zimmer and the FDA, it is believed the defective implant devises were manufactured between March 31, 2015 and April 20, 2015. The official name of the defective hip implant is the Zimmer® M/L Tapers, with Kinectiv Technology, Prosthesis Femoral Stems and Necks. The component parts are made of a Titanium blend of specific metal alloys thought to be especially effective for patients with a high sensitivity to metal. The design of orthopedic implants are complicated and the component parts are often made of different “biomaterials.” This product was marketed to doctors as having greater flexibility because of the implant’s design; it allows the surgeon to adjust leg length, optimize range of motion, and regulate hip joint stability based on the individual needs of the patient.
Generally speaking, products liability (or defective product) cases in Florida fall under one of two legal theories: strict products liability or negligence. That said, oftentimes there is an overlap in the analysis of the facts and the evaluation process itself may be complicated, which is why it is best to consult an experienced attorney to determine if you have been injured by a defective product. For purposes of this article and a simple overview of some of the issues involved, strict products liability cases (also called liability without fault) tend to look at the “design” of the product and ask, “Did the injury occur because the product is defectively designed and therefore unreasonably dangerous?” On the other hand, cases based in negligence tend to look at the manufacturing process and ask, “Did the injury result from how the product was constructed or manufactured, rather than from a problem with its design?”