Zimmer Biomet Hips Recalled for Contamination with Manufacturing ResiduesApr 4, 2016
The residues on the Zimmer hip components can cause serious health issues including allergic reactions, pain, infections, or death. Patients who have received these hip implants may need revision surgery to replace the affected implant with a new device.
The femoral stems and necks are made of a proprietary metal alloy. A monitoring failure during manufacturing led contamination of the hips. During the manufacturing process, metal shavings "can fly off during the machining and milling," Qmed reports. After manufacturing, the product is still coated with the residue of fluids used in the machining process. The hip components can also be contaminated by microbiological and particulate debris. If residues are not removed after manufacturing, they can cause health problems for the patient who is implanted with the device.
The Food and Drug Administration (FDA) categorizes this as a Class I recalls, which is the agency's most serious recall category. Class I recalls are reserved for situations which there is a reasonable probability that use of the affected product will cause serious adverse health consequences or death. During hip replacement surgery, damaged portions of the hip joint are removed and replaced with an integrated system of components that includes the femoral stem and neck. Zimmer says its Kinectiv Technology "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."
Zimmer notified distributors and customers of the recall and provided instructions to distributors and hospitals. Hospitals were directed to remove the recalled devices from inventory and quarantine the devices until they could be returned to Zimmer. The company also asked hospitals to identify the surgeons who have implanted these Zimmer hips so they can be asked to monitor their patients for signs of injury or illness.
The FDA encourages doctors and consumers to report adverse reactions or quality problems with these products to the MedWatch Safety Information and Adverse Event Reporting program.