BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 44

    MDR report key: 2060461 · Received April 6, 2011

    Report

    Report Number
    1818910-2011-05791
    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

    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

    CORRECTED: BRAND NAME, COMMON DEVICE NAME, CATALOG #/LOT #, IMPLANT DATE, EXPLANT DATE, PMA/510(K) #, MANUFACTURE DATE, REPORTING NUMBER. THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN (B)(4) 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.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THAT AFTER SURGERY, PATIENT'S HIP BEGAN TO SLIP AND GRIND. PATIENT HAS HAD PROBLEMS MAINTAINING BALANCE. DUE TO THE CONSTANT PAIN, PATIENT LIMPS. PATIENT ALSO SUFFERS FROM THE EFFECTS OF METALLOSIS, INCLUDING RASHES, ITCHING, STRANGE SORES AND ULCERS, NEUROLOGICAL ISSUES AND INABILITY TO SLEEP DUE TO THE ALMOST INTOLERANT, CONSTANT, AND SEVERE PERSISTENT PAIN. IT IS DIFFICULT FOR THE PATIENT TO WALK, MOVE HER LEGS, AMBULATE, OR ENGAGE IN MOST ACTIVITIES OF DAILY LIVING. PHYSICIANS HAVE EXAMINED AND ADVISED PATIENT SHE SUFFERS FROM SUBSTANTIALLY ELEVATED, IF NOT TOXIC, LEVELS OF METAL IONS IN HER BLOOD STREAM AND POOLING OF HEAVY METALS AS A RESULT OF THE FAILURE OF HER ASR HIP. PATIENT'S PHYSICIAN HAS ADVISED HER THAT SHE IS SUFFERING LOSS OF MUSCLE MASS AND DETERIORATION OF THE SOFT TISSUE IN HER HIP. PATIENT IS SCHEDULE FOR REVISION SURGERY ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 44 NONE KWA DEPUY INTERNATIONAL, LTD. NA 2172337

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention