BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ASR FEMORAL HEAD

    MDR report key: 2071637 · Received April 15, 2011

    Report

    Report Number
    1818910-2011-06266
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    October 27, 2010
    Report Date
    March 18, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KXA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    ATTORNEY

    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.

    Additional Manufacturer Narrative · 1

    THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. FURTHER INVESTIGATION OF THIS INDIVIDUAL INCIDENT WILL NOT BE UNDERTAKEN, AS THERE IS AN ONGOING INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS. REF. (B)(4). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE PATIENT UNDERWENT A SURGICAL PROCEDURE THAT WOULD NOT HAVE BEEN NEEDED IF THE ASR HAD PERFORMED SATISFACTORILY DURING ITS EXPECTED USEFUL LIFE; IS PERMANENTLY HARMED BY METAL POISONING AND METALLOSIS FROM THE METAL DEBRIS; LOST WAGES AND FUTURE LOSS OF EARNING CAPACITY; INCURRED MEDICAL EXPENSES AND WILL INCUR ADDITIONAL MEDICAL EXPENSES IN THE FUTURE; AND IS PERMANENTLY HARMED, BECAUSE OF COMPLICATIONS NORMALLY ASSOCIATED WITH A SECOND HIP REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY ASR FEMORAL HEAD NONE KXA DEPUY INTERNATIONAL, LTD. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention