Device product
LUSTER HIP SZ 7 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-1921-2012
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-1921-2012
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:152180007 and Lot numbers: A1XEF1000, A21BV1000, A4NBV1000, A6BB31000, AB1H31000, AV1A71000, AV7FL1000, BB8E21000, BV8FT1000, VG3BSB000, X5XD21000, Y64ET1000, Z12DG1000, and Z1PJE1000.
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