Device product
PFC SIGMA Cruciate Retaining (CR); Cemented Femoral devices; (Size 5/RT) Used during primary total knee arthroplasty to improve patient mobility.
Z-1077-2014
Product summary
- Event
- Event 67159
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2
- Official record key
device-enforcement:Z-1077-2014
Official wording
Reason: Knee implant femoral devices were found to have anomalous microstructure. Porosity and the presence of blocky carbides, within the cobalt chrome part, can decrease the overall fatigue strength. This decrease in strength could cause implants to fracture under what would normally be acceptable loads.
Code information: Catalog Number 960015 Lot Numbers 7810268 and 7806929 (US) Lot Number 7806934 (OUS)
Distribution pattern: Worldwide Distribution-USA including the states of IA, CA, KY, and FL, and the countries of Finland, Germany, Sweden, and Czech Republic.
Derived failure modes
-
Unknown
Knee implant femoral devices were found to have anomalous microstructure. Porosity and the presence of blocky carbides, within the cobalt chrome part, can decrease the overall fatigue strength. This decrease in strength could cause implants to fracture under what would normally be acceptable loads.