BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY LINER

    MDR report key: 1222442 · Received November 4, 2008

    Report

    Report Number
    1818910-2008-05151
    Event Type
    Injury
    Date Received
    November 4, 2008
    Date of Event
    October 24, 2008
    Report Date
    October 24, 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
    IL, US
    Reporter Occupation
    PHYSICIAN

    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 21 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 OF THE LINER AND OSTEOLYSIS

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention