DePuy LCS Knee Prosthesis Recalled for Higher Revision Rates
DePuy Orthopaedics is recalling LCS COMPLETE RPS knee inserts because they show higher revision rates in Australia when the patella is not resurfaced.
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: The recall is classified as FDA Class II, and the source describes a risk of harm (patello-femoral pain and potential secondary procedure) without reporting specific injuries or fatalities, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
DePuy Orthopaedics, Inc. is recalling 28,732 units of LCS COMPLETE RPS inserts, which are knee prosthesis components used in orthopedic surgery. The recall covers various sizes and all lots, identified by specific catalog numbers listed in the agency record.
The recall was initiated because the LCS COMPLETE RPS Knee System has higher rates of revision in Australia when the native patella is not resurfaced, compared to other unresurfaced posterior-stabilized implants. If the system is implanted without resurfacing the native patella, patients may experience patello-femoral pain, which could potentially require a secondary procedure.
The affected products were distributed nationwide in the United States and in several international countries, including Canada, Australia, Austria, Belgium, the UK, France, Greece, Ireland, Israel, Italy, Korea, Luxembourg, Malaysia, the Netherlands, New Zealand, Norway, South Africa, Switzerland, and Thailand. Healthcare providers and patients should consult with their orthopedic surgeons regarding the specific risks and potential need for follow-up care.
The recalled product
- Product
- LCS COMPLETE RPS inserts, various sizes. Knee prosthesis component for orthopedic surgery.
- Manufacturer
- DePuy Orthopaedics, Inc.
- Hazard
- Affected units
- 28,732
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by DePuy Orthopaedics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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