BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLOBAL AP BALL CYLIN TRL ASSEM

    MDR report key: 1020998 · Received March 26, 2008

    Report

    Report Number
    1818910-2008-01108
    Event Type
    Injury
    Date Received
    March 26, 2008
    Date of Event
    March 21, 2008
    Report Date
    March 21, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PROVIDED INFO STATES, THE TRIALS WERE MISTAKENLY IMPLANTED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADD'L INFO BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    BROACH WITH TRIAL BALL IMPLANTED INTO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLOBAL AP BALL CYLIN TRL ASSEM 87LXH LXH DEPUY ORTHOPAEDICS, INC. NA B2FEY1000

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other