BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY LINER

    MDR report key: 1211037 · Received October 23, 2008

    Report

    Report Number
    1818910-2008-04902
    Event Type
    Injury
    Date Received
    October 23, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 1, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWB
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION/ERROR REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THIS INVESTIGATION CLOSED. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION THAT CHANGES THIS CONCLUSION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PATIENT REVISED TO ADDRESS POLYETHYLENE WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY LINER TOTAL HIP REPLACEMENT KWB DEPUY ORTHOPAEDICS, INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention