Published on June 20, 2015
Zimmer has announced a voluntary recall of its M/L Taper with Kinectiv Technology Femoral Stems and Necks used in hip replacements, because higher than expected amounts of manufacturing residues were left on the devices. Zimmer calls this a “process monitoring failure”; you’d probably call it not cleaning the parts properly before putting them on the market. The FDA announced the Class 1 Recall, the most serious type of recall, as use of the products will cause serious adverse medical consequences or even death. Affected products were manufactured and distributed between March 31, 2015 and April 20, 2015. If you had a hip replaced in 2015, call Thornton Law Firm today at 888-491-9726 for a free evaluation of your potential legal claim, or tell us your story using our secure online form.
The M/L Taper with Kinectiv Technology femoral stems and necks are Tivanium® alloy implants that the surgeon uses to fit the artificial hip to the existing bone. The damaged parts of the femur are removed and replaced with a system of artificial products, which includes the femoral neck – the thinner part of the femur next to the ball of the joint – and the femoral stem, the longer part of the bone tapering down from the femoral neck.
The higher than expected levels of manufacturing residue on the parts may lead to serious health consequences. The FDA warns that patients and doctors should be alert for allergic reactions, pain, infections, or even death after a hip replacement using these recalled Zimmer parts. A second hip replacement surgery – a revision – may be required to remove the defective parts. A hip revision involving the neck and stem is very invasive as the femoral stem must be disconnected from the existing bone to which it was attached during the first surgery.
This is Zimmer’s second Class 1 Recall in the last three months. Zimmer announced in March that it was voluntarily recalling its Zimmer Persona Trabecular Metal Tibial Knee Implant after an unexpectedly high complaint rate of 61% was reported. That device, which was marketed as giving a superior, more accurate fit, actually was loosely fitted, with space between the implant and the bone, leading to swelling, severe pain, tissue damage, bone damage, and possibly revision surgery.
If you or a loved one had a hip replacement using Zimmer M/L Taper femoral necks or stems, and have experienced complications including allergic reactions, pain, infections, revision surgery, or even death, you may have a legal claim against Zimmer. The medical device team at Thornton Law Firm specializes in helping patients nationwide who have been injured by defective medical devices like the Zimmer M/L Taper hip replacement parts. For a free, confidential evaluation of your legal rights, contact us at 888-491-9726 or tell us your story here.
