BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLOBAL SHD HYL PEG GLENOID 48

    MDR report key: 2052682 · Received April 7, 2011

    Report

    Report Number
    1818910-2011-05936
    Event Type
    Injury
    Date Received
    April 7, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 14, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWS
    PMA / PMN Number
    K944538
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO PRIOR REPORTS FOR THIS PART AND LOT NUMBER COMBINATION. PROVIDED INFO MARKED ON THE DEVICE EXPERIENCE REPORT IS MARKED THAT THE PRODUCTS ARE NOT SUSPECTED OF FAILING TO MEET SPECS OR CONTRIBUTING TO THE REPORTED EVENT. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFO PROVIDED. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY 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

    PT WAS REVISED TO ADDRESS LOOSENING OF THE GLENOID COMPONENT AT THE CEMENT/IMPLANT INTERFACE. THE MFR OF THE CEMENT USED IN THE PRIMARY SURGERY IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLOBAL SHD HYL PEG GLENOID 48 87HRY; 87HSX; 87JDB; 87JDI; 87JWH; 87KWA; 87KWT KWS DEPUY ORTHOPAEDICS, INC. NA RN7C41

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention