BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT36IDX50OD

    MDR report key: 2011289 · Received March 4, 2011

    Report

    Report Number
    1818910-2011-02540
    Event Type
    Injury
    Date Received
    March 4, 2011
    Date of Event
    February 3, 2011
    Report Date
    February 3, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD
    Product Code
    KWA
    PMA / PMN Number
    K062426
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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

    PT WAS REVISED TO ADDRESS LOOSENING OF THE CUP, WHICH HAD ALSO MOVED FROM ITS ORIGINAL POSITION. OSTEOLYSIS WAS ALSO REPORTED, AND THE PT HAD ELEVATED CHROMIUM LEVELS, AS WELL AS METAL DEBRIS IN SOFT TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE MTL INS NEUT36IDX50OD 87KWA KWA DEPUY INTERNATIONAL, LTD NA 2458357

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention NA.