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U.S. Department of Health and Human Services

Enforcement Report - Week of July 11, 2012

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Event Detail

Event ID 61749
Product Type Devices
Status Ongoing
Recalling Firm DePuy Orthopaedics, Inc.
City Warsaw
State IN
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-05-16
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Nationwide Distribution-including the states of CA, CO, IA, NC, OH, TX, WA, WI, and WV.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
LUSTER HIP SZ 10 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. Product code:152180010 and Lot numbers: A4VCY1000 and T76A61007. Class II 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 ULTIMA LX Cemented Polished Femoral Hip Stems, could potentially exhibit corrosion of the polished surfaces within the cement mantle. This corrosion may in turn lead to an increased incidence of peri-prosthetic soft tissue necrosis. 85) LUSTER Cemented Polished Femoral Hip Stems in 69 lots Z-1924-2012
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. Product code:152180003 and Lot numbers: A46D71000, A52C11000, A88D11000, AY2CE1000, B1XGV1000, BA3BF1000, BC6BC1000, BX9B71000, Y97FM1000, and Z5NBJ1000. Class II 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 ULTIMA LX Cemented Polished Femoral Hip Stems, could potentially exhibit corrosion of the polished surfaces within the cement mantle. This corrosion may in turn lead to an increased incidence of peri-prosthetic soft tissue necrosis. (85) LUSTER Cemented Polished Femoral Hip Stems in 69 lots Z-1917-2012
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. Product code:152180007 and Lot numbers: A1XEF1000, A21BV1000, A4NBV1000, A6BB31000, AB1H31000, AV1A71000, AV7FL1000, BB8E21000, BV8FT1000, VG3BSB000, X5XD21000, Y64ET1000, Z12DG1000, and Z1PJE1000. Class II 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 ULTIMA LX Cemented Polished Femoral Hip Stems, could potentially exhibit corrosion of the polished surfaces within the cement mantle. This corrosion may in turn lead to an increased incidence of peri-prosthetic soft tissue necrosis. (85) LUSTER Cemented Polished Femoral Hip Stems in 69 lots Z-1921-2012
LUSTER HIP SZ 6 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. Product code:152180006 and Lot numbers: A21BR1000, A4CD61000, AR1C81000, BB8E31000, V2RCB1005, W4GCP1007, WR6EXA000, WS3GX1003, X5SFN1000, X68GE1000, Y47BLA000, Y4HA21000, Z1TD71000, and Z66H41000. Class II 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 ULTIMA LX Cemented Polished Femoral Hip Stems, could potentially exhibit corrosion of the polished surfaces within the cement mantle. This corrosion may in turn lead to an increased incidence of peri-prosthetic soft tissue necrosis. (85) LUSTER Cemented Polished Femoral Hip Stems in 69 lots Z-1920-2012
LUSTER HIP SZ 5 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. Product code:152180005 and Lot numbers: AH7DVA000 and VJ3B21003. Class II 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 ULTIMA LX Cemented Polished Femoral Hip Stems, could potentially exhibit corrosion of the polished surfaces within the cement mantle. This corrosion may in turn lead to an increased incidence of peri-prosthetic soft tissue necrosis. (85) LUSTER Cemented Polished Femoral Hip Stems in 69 lots Z-1919-2012
LUSTER HIP SZ 4 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. Product code:152180004 and Lot numbers: A4VCX1000, A55MG1000, A88F41000, AT4FH1000, BC5E51000, BJ4JP1000, BS3FN1000, BX9B81000, and ZV1FH1000. Class II 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 ULTIMA LX Cemented Polished Femoral Hip Stems, could potentially exhibit corrosion of the polished surfaces within the cement mantle. This corrosion may in turn lead to an increased incidence of peri-prosthetic soft tissue necrosis. Eighty-five (85) LUSTER Cemented Polished Femoral Hip Stems in 69 lots Z-1918-2012
LUSTER HIP SZ 9 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. Product code:152180009 and Lot numbers: AE9GG1000, AH7DW1000, U5TA2C000, V1YEE1001, W1CBL1001, W5RF41001, W5RF41007, and Y84DW1000. Class II 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 ULTIMA LX Cemented Polished Femoral Hip Stems, could potentially exhibit corrosion of the polished surfaces within the cement mantle. This corrosion may in turn lead to an increased incidence of peri-prosthetic soft tissue necrosis. (85) LUSTER Cemented Polished Femoral Hip Stems in 69 lots Z-1923-2012
LUSTER HIP SZ 8 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. Product code:152180008 and Lot numbers: A5BDJ1000, A73C51000, AH6D21000, X4GBW1000, and Z2YCR1000. Class II 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 ULTIMA LX Cemented Polished Femoral Hip Stems, could potentially exhibit corrosion of the polished surfaces within the cement mantle. This corrosion may in turn lead to an increased incidence of peri-prosthetic soft tissue necrosis. (85) LUSTER Cemented Polished Femoral Hip Stems in 69 lots Z-1922-2012
LUSTER HIP SZ 2 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. Product code:152180002 and Lot numbers: A4TEH1000, A71EE1000, WF8A81001, X43FG1000, and Y82BD1000. Class II 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 ULTIMA LX Cemented Polished Femoral Hip Stems, could potentially exhibit corrosion of the polished surfaces within the cement mantle. This corrosion may in turn lead to an increased incidence of peri-prosthetic soft tissue necrosis. (85) LUSTER Cemented Polished Femoral Hip Stems in 69 lots Z-1916-2012
LUSTER HIP SZ 1 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. Product code: 152180001 and Lot numbers: A4TEH1000, A71EE1000, WF8A81001, X43FG1000, and Y82BD1000. Class II 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 ULTIMA LX Cemented Polished Femoral Hip Stems, could potentially exhibit corrosion of the polished surfaces within the cement mantle. This corrosion may in turn lead to an increased incidence of peri-prosthetic soft tissue necrosis. (85) LUSTER Cemented Polished Femoral Hip Stems in 69 lots Z-1915-2012
ULTIMA*LX STM,POL 10/12TAP/4M Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped. Intended Use: The ULTIMA LX 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. Product code: 853159 and Lot numbers: 438756, 438885, 577073, 633711, 660443, 663756, and XCE43. Class II 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 ULTIMA LX Cemented Polished Femoral Hip Stems, could potentially exhibit corrosion of the polished surfaces within the cement mantle. This corrosion may in turn lead to an increased incidence of peri-prosthetic soft tissue necrosis. 431 ULTIMA LX Cemented Polished Femoral Hip Stems in 78 lots Z-1914-2012
ULTIMA*LX STM,POL 10/12TAP/3M Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped. Intended Use: The ULTIMA LX 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. Product code: 853158 and Lot numbers: 550633, 642337, XDG35, XDG36, XED10, XFE24, XHL14, XHL15, YAX31, and YGN25. Class II 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 ULTIMA LX Cemented Polished Femoral Hip Stems, could potentially exhibit corrosion of the polished surfaces within the cement mantle. This corrosion may in turn lead to an increased incidence of peri-prosthetic soft tissue necrosis. 431 ULTIMA LX Cemented Polished Femoral Hip Stems in 78 lots Z-1913-2012
ULTIMA*LX STM,POL 10/12TAP/2M Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped. Intended Use: The ULTIMA LX 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. Product code: 853157 and Lot numbers: 475235, 639640, 640919, 662465, XBK76, XCE42, XCU47, XEW27, XFE23, XFX43, XHL13, YAX30, YDW82, YEK32, YFE46, and YKK07. Class II 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 ULTIMA LX Cemented Polished Femoral Hip Stems, could potentially exhibit corrosion of the polished surfaces within the cement mantle. This corrosion may in turn lead to an increased incidence of peri-prosthetic soft tissue necrosis. 431 ULTIMA LX Cemented Polished Femoral Hip Stems in 78 lots Z-1912-2012
ULTIMA*LX STM,POL 10/12TAP/1M Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped. Intended Use: The ULTIMA LX 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. Product code: 853156 and Lot numbers: 438753, 438882, 633709, 577070U, XBK75, XCE41, XCU45, XFE22, XHL11, and XHL12 Class II 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 ULTIMA LX Cemented Polished Femoral Hip Stems, could potentially exhibit corrosion of the polished surfaces within the cement mantle. This corrosion may in turn lead to an increased incidence of peri-prosthetic soft tissue necrosis. 431 ULTIMA LX Cemented Polished Femoral Hip Stems in 78 lots Z-1911-2012
ULTIMA*LX STM,POL 10/12TAP/SZ5 Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped. Intended Use: The ULTIMA LX 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. Product code: 853155 and Lot numbers: 438752, 475234, 633707, and XBK74. Class II 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 ULTIMA LX Cemented Polished Femoral Hip Stems, could potentially exhibit corrosion of the polished surfaces within the cement mantle. This corrosion may in turn lead to an increased incidence of peri-prosthetic soft tissue necrosis. 431 ULTIMA LX Cemented Polished Femoral Hip Stems in 78 lots Z-1910-2012
ULTIMA*LX STM,POL 10/12TAP/SZ4 Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped. Intended Use: The ULTIMA LX 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. Product code: 853154 and Lot numbers: 438751, 438880, 633705, XCU43, and XFE21 Class II 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 ULTIMA LX Cemented Polished Femoral Hip Stems, could potentially exhibit corrosion of the polished surfaces within the cement mantle. This corrosion may in turn lead to an increased incidence of peri-prosthetic soft tissue necrosis. 431 ULTIMA LX Cemented Polished Femoral Hip Stems in 78 lots Z-1909-2012
ULTIMA*LX STM,POL 10/12TAP/SZ3 Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped. Intended Use: The ULTIMA LX 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. Product code: 853153 and Lot numbers: 438750, 604146, 660441, 0858531531, XCU42, XFE20, YAX29, YCT82, and YEG20. Class II 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 ULTIMA LX Cemented Polished Femoral Hip Stems, could potentially exhibit corrosion of the polished surfaces within the cement mantle. This corrosion may in turn lead to an increased incidence of peri-prosthetic soft tissue necrosis. 431 ULTIMA LX Cemented Polished Femoral Hip Stems in 78 lots Z-1908-2012
ULTIMA*LX STM,POL 10/12TAP/SZ2 Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped. Intended Use: The ULTIMA LX 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. Product code: 853151and Lot numbers: 438748, 438877, 475209, XBG33, XED09, and YFE44. Class II 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 ULTIMA LX Cemented Polished Femoral Hip Stems, could potentially exhibit corrosion of the polished surfaces within the cement mantle. This corrosion may in turn lead to an increased incidence of peri-prosthetic soft tissue necrosis. 431 ULTIMA LX Cemented Polished Femoral Hip Stems in 78 lots Z-1907-2012
ULTIMA*LX STM,POL 10/12TAP/SZ1 Packaging: The product was packaged within inner and outer PETG blister trays and sealed with coated Tyvek lids. Foam protectors were in direct contact with the stem to help immobilize the product within the package. The sterile barrier system was then packed within a carton and shrink wrapped. Intended Use: The ULTIMA LX 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. Product code: 853151and Lot numbers: 438748, 438877, 475209, XBG33, XED09, and YFE44. Class II 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 ULTIMA LX Cemented Polished Femoral Hip Stems, could potentially exhibit corrosion of the polished surfaces within the cement mantle. This corrosion may in turn lead to an increased incidence of peri-prosthetic soft tissue necrosis. 431 ULTIMA LX Cemented Polished Femoral Hip Stems in 78 lots Z-1906-2012
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