BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY CUP

    MDR report key: 1222451 · Received November 4, 2008

    Report

    Report Number
    1818910-2008-05123
    Event Type
    Injury
    Date Received
    November 4, 2008
    Date of Event
    October 15, 2008
    Report Date
    October 15, 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
    GA, 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 PRODUCT AND LOT CODES WERE UNAVAILABLE. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION/ERROR WITH REGARD TO THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS LOOSENING AND ROTATION OF THE CUP AND OSTEOLYSIS (LEFT SIDE).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention