BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE SECTOR II CUP 52MM

    MDR report key: 1243106 · Received November 21, 2008

    Report

    Report Number
    1818910-2008-05118
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 24, 2008
    Report Date
    October 24, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWA
    PMA / PMN Number
    K073504
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    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

    PATIENT WAS REVISE TO ADDRESS FAILURE OF THE LOCKING MECHANISM RESULTING IN DISASSOCIATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE SECTOR II CUP 52MM 87KWA KWA DEPUY ORTHOPAEDICS, INC. NA Z32GE1000

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention