BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE 100 ACET CUP 52MM

    MDR report key: 819227 · Received February 14, 2007

    Report

    Report Number
    1818910-2007-00347
    Event Type
    Injury
    Date Received
    February 14, 2007
    Date of Event
    January 19, 2007
    Report Date
    January 19, 2007
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HXO
    PMA / PMN Number
    k000306
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    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

    DURING THE PRIMARY SURGERY, THE ROD ON THE ANGLED INSERTER SNAPPED AND BROKE DURING USE. THE CUP COULD NOT BE REMOVED FROM THE END TO THE INSERT. ANOTHER CUP WAS OPENED AND USED WITHOUT INCIDENT. THE SURGERY WAS DELAYED APPROXIMATELY 20 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE 100 ACET CUP 52MM 87 LPH HXO DEPUY ORTHOPAEDICS, INC. NA AK6FF1000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA