BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR XL FEM IMP SZ 49

    MDR report key: 1822510 · Received August 27, 2010

    Report

    Report Number
    1818910-2010-05981
    Event Type
    Injury
    Date Received
    August 27, 2010
    Date of Event
    July 30, 2010
    Report Date
    July 30, 2010
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    JDI
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO 510(K) NUMBER PROVIDED BECAUSE THIS IMPLANT IS SOLD INTERNATIONALLY WITH DIFFERENT INDICATIONS FOR USE; IT IS CURRENTLY SOLD IN THE UNITED STATES UNDER A DIFFERENT PART NUMBER. 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

    PATIENT PRESENTED WITH SEVERE PAIN AND A LUMP IN THEIR HIP AREA 6 MONTHS FOLLOWING THR WITH SUMMIT ASR. FROM X-RAYS, CUP LOOKS WELL POSITIONED AND WELL INGROWN. THE SURGEON REMOVED THE ASR HEAD AND ON THE TAPER OF THE STEM AND HEAD, THERE WAS A VERY PROMINENT BLACK MARK AND SIGNS OF WEAR. IT IS CONFIRMED THAT THE PATIENT HAS ALVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY ASR XL FEM IMP SZ 49 TOTAL HIP REPLACEMENT JDI DEPUY INTERNATIONAL, LTD. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention