BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODULAR CATHCART BALL 48MM OD

    MDR report key: 1923640 · Received December 9, 2010

    Report

    Report Number
    1818910-2010-09809
    Event Type
    Injury
    Date Received
    December 9, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 9, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LZY
    PMA / PMN Number
    K903084
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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 COMPLAINED OF GROIN PAIN. PT WAS REVISED TO CONVERT HEMI HIP TO TOTAL HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODULAR CATHCART BALL 48MM OD 87LZY LZY DEPUY ORTHOPAEDICS, INC. NA AD4BG1

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention