Device product
LUSTER HIP SZ 3 Packaging: The product was packaged within inner and outer blister trays, sealed with coated Tyvek lidding. The stems were packaged within vinyl protectors, with foam taper protectors. Intended Use: The LUSTER Cemented Polished Femoral Hip Stems product are forged CoCr polished cemented stems which are used as part of a total hip arthroplasty. These stems were indicated for use with all DePuy bearings and acetabular cups.
Z-1917-2012
Product summary
- Event
- Event 61749
- Status
- Terminated
- Classification
- Class II
- Quantity
- (85) LUSTER Cemented Polished Femoral Hip Stems in 69 lots
- Official record key
device-enforcement:Z-1917-2012
Official wording
Reason: DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction (monoblock or modular)).The LUSTER Cemented Polished Femoral Hip Stems and the U
Code information: Product code:152180003 and Lot numbers: A46D71000, A52C11000, A88D11000, AY2CE1000, B1XGV1000, BA3BF1000, BC6BC1000, BX9B71000, Y97FM1000, and Z5NBJ1000.
Distribution pattern: Nationwide Distribution-including the states of CA, CO, IA, NC, OH, TX, WA, WI, and WV.
Derived failure modes
-
Unknown
DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femoral Hip Stems and the ULTIMA LX Cemented Polished Femoral Hip Stems that were implanted with any metal-on-metal (MoM) articulation (including a head of CoCr and an acetabular cup where the cup is of an all metal construction (monoblock or modular)).The LUSTER Cemented Polished Femoral Hip Stems and the U