DePuy LCS COMPLETE RPS Femoral Implants Recalled for Patello-femoral Pain Risk
DePuy Orthopaedics is recalling 19,059 LCS COMPLETE RPS Femoral Implants because they are associated with higher revision rates and potential patello-femoral pain when the native patella is not resurfaced.
What this means for you
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 hazard involves a risk of harm (patello-femoral pain and potential secondary procedure) without reported fatalities or hospitalizations, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
DePuy Orthopaedics, Inc. is recalling 19,059 units of LCS COMPLETE RPS Femoral Implants, which are knee prosthesis components used in orthopedic surgery. The recall covers various sizes and orientations of the implants, including specific catalog numbers listed in the agency's documentation.
The recall is issued because the LCS COMPLETE RPS Knee System has shown higher rates of revision in Australia when the native patella is not resurfaced, compared to other unresurfaced posterior-stabilized implants. If the implant is used 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. Patients who have received these implants should contact their healthcare provider to discuss their specific clinical situation and any potential symptoms.
The recalled product
- Product
- LCS COMPLETE RPS Femoral Implants, various sizes and orientation. Knee prosthesis component for orthopedic surgery.
- Manufacturer
- DePuy Orthopaedics, Inc.
- Hazard
- Affected units
- 19,059
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.
See all 2 products in this recall →Related recalls
Same manufacturer · DePuy Orthopaedics, Inc.
See all →- HighATTUNE AFFIXIUM Knee Implant Component Recalled for Incorrect Labeling
FDA (Devices) · 2024-04-10
- HighAttune Revision Limb Preservation System Tibial Insert Recalled for Over-Irradiation
FDA (Devices) · 2023-03-29
- HighDePuy Attune Tibial Insert Recalled for Excessive Radiation Exposure
FDA (Devices) · 2023-03-29
- HighOrthopedic Implant Recall: Excessive Radiation Exposure in Revision Tibial Insert
FDA (Devices) · 2023-03-29
- HighOrthopedic Tibial Insert Recalled Due to Excessive Radiation Exposure
FDA (Devices) · 2023-03-29
Same hazard · pain
See all →- HighCartiva Synthetic Cartilage Implants Recalled Due to Higher Complication Rates
FDA (Devices) · 2024-12-11
- SevereHologic BioZorb Radiographic Marker Recalled Due to Serious Injury Reports
FDA (Devices) · 2024-12-04
- SevereHologic BioZorb Bioabsorbable Markers Recalled for Adverse Events
FDA (Devices) · 2024-05-15
- HighSurgical Mesh Recalled Due to Incorrect Collagen Film Placement
FDA (Devices) · 2023-03-08
- HighNuvasive Precice Bone Transport Nail Recalled for Biological Safety Concerns
FDA (Devices) · 2021-04-07