BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM CUP ACE, ZTT-2 L32, 54DP

    MDR report key: 1040472 · Received May 8, 2008

    Report

    Report Number
    1818910-2008-01808
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    May 1, 2008
    Report Date
    May 1, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS INC., DEPUY-RAYNHAM
    Product Code
    LPH
    PMA / PMN Number
    K951000
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE DEVICES WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS WAS ALSO NOT POSSIBLE AS THE LOT CODES REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. ALTHOUGH UNAVAILABLE FOR EVALUATION, IT WOULD NOT BE UNREASONABLE TO EXPECT POLY MATERIAL WEAR AFTER APPROX 17 YEARS OF IMPLANTATION. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION/ERROR WITH REGARD TO THE REPORTED EVENT WITH THE INFO AVAILABLE. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS POLY WEAR, OSTEOLYSIS, AND LOOSENING OF THE CUP (RIGHT SIDE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S-ROM CUP ACE, ZTT-2 L32, 54DP 87LPH LPH DEPUY ORTHOPAEDICS INC., DEPUY-RAYNHAM NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention