The recall is due to manufacturing residues, which can be an issue in the machining and milling of such parts.
|The Zimmer M/L taper hip prosthesis, as shown in a Zimmer surgical technique guide.|
FDA recently announced a Class I designation for a Zimmer hip replacement parts recall.
Certain Zimmer M/L taper with Kinectiv technology femoral stems and necks have "unexpected amounts of manufacturing residues" that can cause serious adverse health issues, including death, according to the agency.
The Zimmer femoral stems and necks are metal alloy implants used for hip replacements that allow the surgeon to fit the implant specifically to the patient. During hip replacement surgery, the damaged portions of the hip joint are removed and replaced with an integrated system of products, which includes the femoral stem and neck inserted into the femur.
The femoral stem and necks are made out of Zimmer's proprietary Tivanium metal alloy.
The affected parts were manufactured and distributed between March 31 and April 20, 2015, the FDA statement said. Warsaw, IN-based Zimmer issued recall notification letters and instructions for distributors and hospital staff on May 18. FDA statement lists the parts being recalled.
The company discovered a process monitoring failure that led to higher than expected amounts of manufacturing residues left on the devices. The residues can cause allergic reactions, pain, infections, or death. No injuries or deaths have been reported, but FDA said that patients who had the parts implanted may need revision surgery.
Zimmer may not be alone when it comes to such residue issues.
In fact, the machining and milling used to produce orthopedic implants are messy operations, John S. Bolinder, vice president of marketing and communications at Nelson Laboratories (Salt Lake City, UT) explained earlier this year at MD&M West. (Note here: Bolinder was not talking about the Zimmer case, but about orthopedic implants in general.)
Shavings from the metal can fly off during the machining and milling, and after the procedure is over, the product is still coated with an aqueous or oil-based residue that were used as cutting fluids in the machining process. Other contaminants include microbiological and particulate debris. Failing to get those manufacturing residues and contaminants off can cause big problems for patients.
|Refresh your medical device industry knowledge at MEDevice San Diego, September 1-2, 2015.|
Nancy Crotti is a contributor to Qmed and MPMN.
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