BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCLAIM ELBOW PIN ASSEMBLY

    MDR report key: 1022564 · Received March 31, 2008

    Report

    Report Number
    1818910-2008-00984
    Event Type
    Injury
    Date Received
    March 31, 2008
    Date of Event
    March 4, 2008
    Report Date
    March 4, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDC
    PMA / PMN Number
    K992656
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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

    PT WAS REVISED TO ADDRESS FRACTURE OF THE POLY LOCKING SLEEVE AND DISASSEMBLY OF THE PIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCLAIM ELBOW PIN ASSEMBLY 87JDC JDC DEPUY ORTHOPAEDICS, INC. NA ZG1C81000

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention