Recall of all Zimmer M/L Taper Hip Prosthesis,
Zimmer M/L Taper with Kinectiv Technology and the Zimmer VerSys head
A typical total hip replacement system consists of four separate components: 1) a femoral stem; 2) a femoral head; 3) a liner; and 4) an acetabular shell. On October 22, 2003, Zimmer received FDA clearance to market a femoral stem under the name of Zimmer M/L Taper Hip Prosthesis (“M/L Taper”). The M/L Taper is constructed from a single piece of Tivanium® Ti-6Al-4V alloy with a porous coating of titanium plasma spray. The neck portion of the stem contains a 12/14 conical taper designed to mate with the corresponding bore taper of a metal or ceramic femoral head.
Zimmer also received FDA clearance to sell a femoral head known as Versys®. The VerSys® head is manufactured from Zimaloy® (a proprietary cobalt-chromium-molybdenum alloy) and intended for use with both Tivanium® and Zimaloy® femoral stems equipped with 12/14 tapered necks.
On July 3, 2007, Zimmer received FDA clearance to market its M/L Taper Hip Prosthesis with Kinectiv® Technology. Zimmer obtained FDA permission by stating that the Kinectiv® was safe and effective and substantial equivalent to the M/L Taper Hip Prosthesis.
The primary difference between the Kinectiv stem and the M/L Taper stem is that the Kinectiv stem has an additional modular junction between the stem body and an interchangeable neck which is also constructed from Tivanium®. This dual-modular stem was introduced in an effort to improve restoration of joint biomechanics. The Kinectiv neck also contains a 12/14 conical threaded taper designed to mate with the corresponding bore taper of a metal or ceramic femoral head.
What Injuries are Associated with these Zimmer Hip Replacement Cases?
Dozens of lawsuits have been filed alleging that the M/L Taper or Kinectiv® when paired with the VerSys® head contains design and manufacturing defects. Plaintiffs allege that micro-movement between the taper of the stems and the head cause fretting and corrosion, resulting in a shedding of metallic particles, specifically cobalt and chromium, from the stem’s taper and from the bore of the femoral head.
Was an M/L Taper, Kinectiv® or VerSys® head used During my Hip Replacement Surgery?
Whenever a medical device is implanted during surgery, a detachable sticker is removed from the device packaging and placed in the patient’s medical record. This sticker has a bar code and identifies the make, model, and lot number of the enclosed parts. This product identification label will tell you exactly what type of components were implanted during your hip replacement surgery. Meshbesher & Spence will obtain these product identification stickers on your behalf from the implanting hospital free of charge.
What Should I do if I Have These Zimmer Products?
If you received these Zimmer products, we recommend asking your doctor about a simple, inexpensive blood test to check your cobalt and chromium levels. If your levels are elevated, it could be a sign that your hip is failing. Cobalt and chromium is measured in “parts per billion” or ppb. Normal cobalt and chromium levels are less than 1ppb. Many people with these products have been found to have cobalt and chromium levels many times higher than normal in their blood.
If you have elevated cobalt and chromium in your blood, your surgeon will likely order a Metal Artifact Reduction Sequence or “MARS” MRI. This is a special type of MRI that is designed to determine whether there is soft tissue damage in your hip or the development of pseudotumors (abnormal pockets of fluid). These soft tissue injuries will not show up on x-rays.
Why Contact Meshbesher & Spence?
Unlike many firms who make big promises and then refer their cases to other attorneys, Meshbesher & Spence will handle your Zimmer hip case from beginning to end.
The lawyers at Meshbesher & Spence have recovered well over $100 million for their drug and medical device clients over the past few years.
If you have suffered injuries as a result of your Zimmer hip replacement components, or if you are unsure about the type of device implanted in your hip, contact Meshbesher & Spence today. Your consultation is free and you pay nothing until our Firm recovers fair compensation for you and your family.
Zimmer M/L Taper Hip Prosthesis Litigation Team