BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ASR CUP

    MDR report key: 1911645 · Received November 29, 2010

    Report

    Report Number
    1818910-2010-09112
    Event Type
    Injury
    Date Received
    November 29, 2010
    Date of Event
    December 10, 2009
    Report Date
    November 17, 2010
    Manufacturer
    DEPUY INT'L., LTD.
    Product Code
    KWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THE PT WAS REVISED TO ADDRESS HIP PAIN. AFTER THE SURGERY, THE SURGEON REPORTED THAT THE PATIENT'S FLESH AROUND THE AFFECTED JOINT WAS BLACK FROM EXPOSURE TO SOME SUBSTANCE, AND OPINED THAT IT WAS METAL FROM THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY ASR CUP TOTAL HIP REPLACEMENT KWA DEPUY INT'L., LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention