BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK DEPUY LINER

    MDR report key: 1080102 · Received July 18, 2008

    Report

    Report Number
    1818910-2008-02570
    Event Type
    Injury
    Date Received
    July 18, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 1, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWB
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE DEVICE WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS WAS ALSO NOT POSSIBLE, AS THE PRODUCT AND LOT CODE WAS UNAVAILABLE. ALTHOUGH UNAVAILABLE FOR EVAL, IT WOULD NOT BE UNREASONABLE TO EXPECT POLY MATERIAL WEAR AFTER APPROX 12 YEARS OF IMPLANTATION. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION/ERROR REGARDING 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 AND OSTEOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK DEPUY LINER TOTAL HIP REPLACEMENT KWB DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention