BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE 300 ACET CUP 56MM

    MDR report key: 1945278 · Received December 30, 2010

    Report

    Report Number
    1818910-2010-10725
    Event Type
    Injury
    Date Received
    December 30, 2010
    Date of Event
    December 3, 2010
    Report Date
    December 3, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWA
    PMA / PMN Number
    K000306
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. ALTHOUGH THE EXACT DATE OF THE PRIMARY SURGERY IS UNKNOWN, IT WAS REPORTED TO HAVE OCCURRED APPROXIMATELY IN (B)(6) 2009.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED TO ADDRESS DISLOCATION ATTRIBUTED TO A MALPOSITIONED CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE 300 ACET CUP 56MM 87KWA, LZO KWA DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Required Intervention NA.