BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLO ANCHOR PEG GLENOID 48 TRL

    MDR report key: 1940888 · Received December 23, 2010

    Report

    Report Number
    1818910-2010-08460
    Event Type
    Injury
    Date Received
    December 23, 2010
    Date of Event
    November 5, 2010
    Report Date
    November 5, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED TRIAL CONFIRMED THE MAJORITY OF THE CENTER PEG BROKE OFF. THE CAUSE IS ATTRIBUTED TO MISUSE AND/OR HEAVY USAGE. THE PRODUCT WAS SEVERELY DAMAGED AND THE VENDOR DATE CODE TO DETERMINE THE AGE WAS WORN OFF. A TWO-YEAR SEARCH OF THE COMPLAINT DATABASE DID NOT IDENTIFY A TREND. BASED ON THE INVESTIGATION THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THE TIP OF THE TRIAL BROKE DURING SURGERY. THE BROKEN TIP WAS NOT RETRIEVED. SURGICAL DELAY OF ONE HOUR IS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLO ANCHOR PEG GLENOID 48 TRL 87LXH LXH DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention