ZIMMER Recalls KINECTIV TIVANIUM HIP STEMS & NECKS

ZIMMER KINECTIV FEMORAL HIP STEMS & NECK IMPLANTS LINKED TO POTENTIAL MANUFACTURING DEFECT

ZimmerKinectivZambrano

by Gabriel F Zambrano

KINECTIV TIVANIUM CLASS 1 RECALL

The U.S. Food & Drug Administration (FDA) issued an important communication confirming that ZIMMER, now known as ZIMMER BIOMET, a major orthopaedic manufacturer, was recalling their M/L TAPER with KINECTIV TECHNOLOGY FEMORAL STEMS & NECKS over a potential manufacturing defect.

KINECTIVZambranoThe implants are used for hip replacements and the proprietary TIVANIUM system allows physicians to fit the implant specifically to the patient. They are marketed as being made out made out of a proprietary TIVANIUM alloy and form part of an integrated neck and stem that literally fit together like a puzzle. This design component makes them similar to the STRYKER REJUVENATE & ABG II that were the subject of lawsuits following a market withdrawal approximately two years ago. The KINECTIV RECALL was initiated June 8, 2015, which means that enough reports were received, or anticipated, that the company elected to take the product off the market.  Zimmer had previously advised medical personnel of their concerns via a May 18, 2015 correspondence. In essence, the company’s recall notification provided the following instructions to distributors and hospital staff as depicted below.

KINECTIVRecall2015

Reportedly, “[t]company found a process monitoring failure that led to higher than expected amounts of manufacturing residues left on the devices. 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 revision surgery to replace the affected implant“. The FDA’s full explanation may be found here.

Per the FDA, the Affected Lot Numbers and Items Descriptions are Listed here. Concerned victims can use this link determine whether or not they have been exposed to this potential risk. Class 1 Recalls are the most serious kinds of recalls because by definition they involve products where a reasonable probability exists that use of the products will cause serious adverse health consequences including the potential for death.

ZimmerKinectiv

ZIMMER promotes the M/L Taper with Kinectiv Technology as a product that allows the surgeon to fit the implant to the patient. It notes that the “keystone” to the Kinectiv Technology is the exclusive use of 0+ Femoral heads which allow for independent adjustment of leg length and offset. Essentially, the product is marketed  as one that allows the surgeon flexibility in using their professional judgment to optimize range of motion, ensure optimum joint stability, equalize leg length and alleviate impingement.

The size of affected products is unclear from information provided above by the FDA. However, some reports indicate the numer of units is limited to 752 total units across the U.S., other countries in North America, Europe and Asia. Specifically, Varun Saxena, of Fierce Medical Devices, reported these numbers in “FDA Announces Class 1 Reall of Zimmer HeartWare & Maquet Devices“. Regardless, these numbers and the uncertainty of the recall are of little solace to potential victims.

KINECTIV †CASE EVALUATION

Please contact our office if your or a loved one need help determining if you have one of the now recalled ZIMMER KINECTIV TIVANIUM FEMORAL STEMS or ZIMMER KINECTIV TIVANIUM NECKS. You can call (954) 524-2820 or e-mail [email protected] for Free Case Evaluation.

 

Shares