BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 48

    MDR report key: 1984407 · Received January 27, 2011

    Report

    Report Number
    1818910-2011-01194
    Event Type
    Injury
    Date Received
    January 27, 2011
    Report Date
    December 28, 2010
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    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.

    Description of Event or Problem · 1

    (B)(6) ALLEGE: BLOOD SPECIMENS TAKEN ON (B)(6) 2010, TESTED BY (B)(6) AND REPORTED ON (B)(6) 2010, REVEAL THAT THE PT HAS AN ABNORMALLY HIGH CHROMIUM LEVEL OF 4.6 MCG/1 (REFERENCE RANGE 1.4 OR LESS) AND AN ABNORMALLY HIGH COBALT LEVEL OF 6.5 MCG11 (REFERENCE RANGE OF 1.8 OR LESS). THESE LEVELS OF TOXICITY ARE A DIRECT RESULT OF METALLOSIS PRODUCED BY THE ASR XL ACETABULAR SYSTEMS IMPLANTED INTO HER LEFT AND RIGHT HIPS. IN ADDITION, BOTH HIP SOCKETS HAVE LOOSENED. DUE TO THE HIGH LEVELS OF TOXICITY AND THE LOOSENING IN THE HIP JOINTS, IN ALL PROBABILITY BOTH ARTIFICIAL HIPS WILL HAVE TO BE REMOVED AND REPLACED IN THE NEAR FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 48 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 2323287

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention