BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 46

    MDR report key: 2060458 · Received April 6, 2011

    Report

    Report Number
    1818910-2011-05987
    Event Type
    Injury
    Date Received
    April 6, 2011
    Report Date
    March 7, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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. (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.

    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

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    BILATERAL PATIENT. LITIGATION PAPERS ALLEGE PT INITIALLY DID WELL AFTER THE HIP REPLACEMENT SURGERIES, MAKING REASONABLE PROGRESS IN PHYSICAL THERAPY AND RECOVERY. HOWEVER, IN 2010, PT BEGAN HAVING PAIN AND PROBLEMS IN HER RIGHT AND LEFT HIP AREAS. THROUGHOUT THE NEXT SEVERAL MONTHS, PT'S PAIN IN HER RIGHT AND LEFT HIPS CONTINUED TO INCREASE. PT ALSO BEGAN EXPERIENCING OTHER PROBLEMS, INCLUDING DIFFICULTY WALKING, AND A "CATCH" IN HER RIGHT AND LEFT HIPS. THE PT ALSO UNDERWENT BLOOD TESTS WHICH DETERMINED SHE HAS HIGHER THAN NORMAL LEVELS OF METAL IONS IN HER BLOOD DUE TO A BREAKDOWN OF THE DEVICE'S METAL COMPONENTS. IT IS FURTHER ALLEGED THE PT WILL BE REQUIRED TO UNDERGO TESTING TO DETERMINE IF HE (SIC) HAS METAL DEBRIS OR PARTICLES IN HIS (SIC) BODY. DOI: (B)(6) 2008 - DOR: NO REVISION REPORTED AT THIS TIME (RIGHT SIDE). DOI: (B)(6) 2009 - DOR: NO REVISION REPORTED AT THIS TIME (LEFT SIDE). PT IS A RESIDENT OF (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 46 FEMORAL HEAD KWA DEPUY INTERNATIONAL, LTD. NA 2624066

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention