ZIMMER RECALLS M/L TAPER HIP STEMS AND NECKS (Orthopedics This Week)
On June 8, 2015, Zimmer Inc. initiated a Class I Recall of its M/L Taper with Kinectiv Technology Femoral Stems and Necks.
Manufacturing Residue
Due to a process monitoring failure, higher-than-expected amounts of manufacturing residues were left on the devices made from March 31, 2015 through April 20, 2015. The 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,” according to the company.
The stems and necks are Tivanium alloy implants used for hip replacements that allow the surgeon to fit the implant specifically to the patient.
According to the FDA, Zimmer issued recall notification letters and instructions for distributors and hospital staff on May 18, 2015.
Recall Instructions
The following instructions were given to distributors:
- “Review the notification and ensure affected personnel are aware of the contents.”
- “Locate all affected product identified in the recall letter and quarantine them immediately.”
- “Carry out a physical count of all affected product in your territory and complete the Inventory Return Certification Form sent by the company. Email a completed copy of the form to postmarket@zimmer.com.”
- “Return the recalled product along with the completed Inventory Return Certification Form.”
Distributors were asked to notify the company of any hospitals to which they “further distributed the affected product. “In addition,” distributors were asked to “identify the surgeons that have implanted this product. Supply that information to the company using the provided spreadsheet template.”
Instructions for hospital staff, including risk managers and surgeons, included:
- “Review the notification and ensure affected personnel are aware of the contents.”
- “Assist your Zimmer sales representative with the quarantine of any affected product.”
- “Your Zimmer sales representative will remove the recalled product from the facility.”
Kinectiv Technology
According to the company, the keystone to Kinectiv technology is the “exclusive use of +0 femoral heads. This allows independent adjustment of leg length and offset since all adjustments are made with the necks. Leg length is of primary concern in total joint replacement for surgeons and patients. Kinectiv Technology allows the surgeon to optimize leg length without affecting offset and conversely offset without affecting leg length.”
Range of motion and joint stability, says the company, is another primary issue. “With the exclusive use of the +0 head, every neck has been optimized to this head length to maximize range of motion. In addition, the ante/retroverted necks allow the surgeon to intraoperatively fine tune the range of motion depending on the patient anatomy and implant position.”
Contacting Zimmer and FDA
If you have questions, contact the Zimmer customer call center at 1-877-946-2761 between 8:00 am and 5:00 pm EST with any questions or concerns.
The FDA encourages healthcare professionals and patients to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report Online: www.fda.gov/MedWatch/report.
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.