BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 50

    MDR report key: 2210469 · Received August 9, 2011

    Report

    Report Number
    1818910-2011-15315
    Event Type
    Injury
    Date Received
    August 9, 2011
    Report Date
    July 15, 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 (B)(6) 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

    CORRECTED: EVENT/PROBLEM DESCRIPTION, EXPLANT DATE. DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGED THE PT SUFFERS FROM ELEVATED, IF NOT TOXIC, LEVELS OF COBALT AND CHROMIUM METAL IONS IN HER BLOOD STREAM DUE TO HER IMPLANT. PT HAS UNDERGONE TWO SEPARATE BLOOD TESTS REVEALING COBALT LEVELS AT 11.0 AND 9.4, AND CHROMIUM LEVELS OF 6.3 AND 6.0.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THE PATIENT SUFFERS FROM ELEVATED, IF NOT TOXIC, LEVELS OF COBALT AND CHROMIUM METAL IONS IN HER BLOODSTREAM DUE TO HER IMPLANT. PATIENT HAS UNDERGONE TWO SEPARATE BLOOD TESTS REVEALING COBALT LEVELS AT 11.0 AND 9.4, AND CHROMIUM LEVELS OF 6.3 AND 6.0. UPDATE: (B)(4) 2012 - THE SALES REP HAS REPORTED THE REVISION SURGERY. PATIENT WAS REVISED TO ADDRESS PAIN AND HIGH METAL ION LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 50 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 2559704

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention