BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER TM REVERSE GLENOSPHERE

    MDR report key: 2994424 · Received March 5, 2013

    Report

    Report Number
    1822565-2013-00423
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    December 19, 2012
    Report Date
    February 5, 2013
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUPPLIED X-RAYS ARE AFTER THE GLENOSPHERE DISASSOCIATED; THEREFORE, A DETERMINATION ON THE PLACEMENT OF THE GLENOSPHERE CANNOT BE MADE. SURGICAL TECHNIQUE STATES; "IF UNABLE TO VISUALLY CONFIRM AN EVEN, CIRCUMFERENTIAL ENGAGEMENT OF THE GLENOSPHERE TO THE BASE PLATE, CONSIDER THE USE OF A FLUOROSCOPE TO AID IN THE CONFIRMATION. SEATING OF THE GLENOSPHERE TO THE BASE PLATE CAN BE EXAMINED IN THE AUXILIARY VIEW OR IN A VIEW PARALLEL TO GLENOID VERSION. THE MEDIAL RIM OF THE GLENOSPHERE SHOULD BE PARALLEL TO THE FACE OF THE BASE PLATE." THE GLENOSPHERE DISASSOCIATION IS MOST LIKELY DUE TO NOT SYMMETRICALLY SEATING THE GLENOSPHERE WITH THE BASE PLATE. AS RETURNED, THE GLENOSPHERE IS IN VERY GOOD CONDITION WITH ONLY MINOR SCRATCHING WHICH IS MOST LIKELY A RESULT OF IT BEING REMOVED FROM THE PT. IT WAS DIMENSIONALLY INSPECTED AND FOUND TO BE CONFORMING WHERE MEASURED. DEVICE HISTORY RECORDS INDICATE ALL COMPONENTS WERE MFG AND INSPECTED TO SPECIFICATION.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED DUE TO THE GLENOSPHERE DETACHING FROM THE BASEPLATE. PROPER SURGICAL TECHNIQUE WAS FOLLOWED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93237 ZIMMER TM REVERSE GLENOSPHERE HSD ZIMMER, INC. 62113939

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention