BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLOBAL SHD HYL PEG GLENOID 44

    MDR report key: 1618497 · Received February 26, 2010

    Report

    Report Number
    1818910-2010-01148
    Event Type
    Injury
    Date Received
    February 26, 2010
    Date of Event
    February 9, 2010
    Report Date
    February 9, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HRY
    PMA / PMN Number
    K944538
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED FOR EXAMINATION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSION REGARDING THE REPORTED EVENT WITH THE INFO AVAILABLE, HOWEVER, ALTHOUGH UNAVAILABLE FOR EVALUATION, IT WOULD NOT BE UNREASONABLE TO EXPECT POLY MATERIAL WEAR AFTER APPROX 15 YRS IMPLANTED. A SEARCH OF THE COMPLAINT DATABASE DID NOT SHOW ANY OTHER REPORTS AGAINST THE REPORTED LOT CODE. 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. SHOULD ANY ADDITIONAL INFO BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    WHILE PT'S SHOULDER WAS BEING REVISED TO ADDRESS PAIN FROM A FRACTURE OF HER SCAPULAR SPINE, THE POLY GLENOID COMPONENT WAS FOUND TO BE DAMAGED AND WORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLOBAL SHD HYL PEG GLENOID 44 87HRY HRY DEPUY ORTHOPAEDICS, INC. NA 745630

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention