by Gabriel F Zambrano
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.
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.
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.
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.