Hip Replacement Prosthesis Recalled Due to Increased Postoperative Fracture Risk
Zimmer hip replacement prostheses are recalled due to increased risk of postoperative femoral fracture. Affected devices are distributed nationwide; patients should consult their surgeon.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with risk of significant patient harm (postoperative femoral fracture) where no illnesses or injuries have been reported. Per rubric, risk-of-harm products without reported injury are classified as High.
Plain-English summary
Zimmer, Inc. is recalling CPT Hip Joint Metal/Polymer Semi-Constrained Cemented Prostheses used in hip replacement surgery. The recall affects approximately 5,500 prostheses distributed in the United States and 242,000 units distributed internationally.
The prostheses have an increased risk of postoperative perisprosthetic femoral fracture—a break in the thighbone near the implant that can occur after surgery. The manufacturer is updating the product Instructions for Use (IFU) to reflect this risk.
Patients who have received this prosthesis, or those scheduled for implantation, should contact their healthcare provider or surgeon to discuss their individual situation. Healthcare providers should review the updated IFU when available.
The recalled product
- Product
- CPT Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis, used in Hip Arthroplasty; Item Numbers 00811400000 00811400010 00811400100 00811400110 00811400200 00811400210 00811400218 00811400230 00811400300 00811400310 00811400318 00811400330 00811400400…
- Manufacturer
- Zimmer, Inc.
Distribution
Distributed nationwide across the United States.
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