BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ASR CUP

    MDR report key: 2163211 · Received July 8, 2011

    Report

    Report Number
    1818910-2011-12655
    Event Type
    Injury
    Date Received
    July 8, 2011
    Report Date
    June 10, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    MM 37-13
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    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 FOLLOWING: PATIENT WAS IMPLANTED WITH A DEPUY ASR HIP ON (B)(6), 2006. ON (B)(6), 2006, PATIENT REPORTED TO DOCTOR WITH PERSISTENT PAIN IN THE ANTEROLATERAL AREA OF HER LEFT THIGH. PATIENT SUFFERED CONSTANT DEBILITATING PAIN THAT DID NOT RESPOND TO THE TREATMENTS ATTEMPTED BY THE DOCTOR. DOCTOR ORDERED A BONE SCAN ON (B)(6), 2007, THAT REVEALED UPTAKE IN KEEPING WITH A LOOSE PROSTHESIS. AT THIS TIME, DOCTOR RECOMMENDED A REVISION OF THE FEMORAL STEM AND HEAD ON (B)(6), 2007. REVISION SURGERY TOOK PLACE ON (B)(6), 2007 (PREVIOUSLY REPORTED TO FDA). PATIENT RETURNED TO DOCTOR ON (B)(6), 2007 WITH CONTINUED COMPLAINTS OF GROIN PAIN AND A CLICKING SOUND EMANATING FROM HER LEFT HIP. PATIENT CONTINUED TO SUFFER DEBILITATING PAIN OVER THE FOLLOWING YEARS THAT WAS NOT RESOLVED BY VARIOUS TREATMENTS ATTEMPTED BY DOCTOR. IN (B)(6) OF 2011, DOCTOR ORDERED BLOOD TESTING TO DETERMINE THE RATE OF METAL ON METAL WEAR DEBRIS. THE RESULTS SHOWED A DANGEROUSLY HIGH LEVEL OF COBALT IN HER SYSTEM, TEN TIMES HIGHER THAN THE ACCEPTABLE RANGE. DUE TO THE HEIGHTENED METAL DEBRIS LEVELS AND CONSTANT PAIN, PATIENT HAS BEEN SCHEDULED FOR REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY ASR CUP ASR ACETABULAR CUPS KWA DEPUY INTERNATIONAL, LTD. NA 1989377

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention