BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRABECULAR METAL REVERSE SHOULDER SYSTEM INSTRUMENTATION BAS

    MDR report key: 852243 · Received May 11, 2007

    Report

    Report Number
    1822565-2007-00132
    Event Type
    Injury
    Date Received
    May 11, 2007
    Date of Event
    April 6, 2007
    Report Date
    April 17, 2007
    Manufacturer
    ZIMMER, INC.
    Product Code
    LXH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: FRACTURE OF GLENOID RIM MIGHT HAVE BEEN CAUSED WHEN REAMING OSTEOPOROTIC BONE USING BASEPLATE REAMER. ALSO 7.5MM DRILL WAS USED TO CREATE HOLE FOR BASEPLATE POST. NORMALLY, WHEN THERE IS GOOD BONE STOCK A 7.5MM DRILL IS USED, WHEN POOR BONE STOCK EXISTS A 7.5MM CORTEX DRILL SHOULD BE USED (SOMETIMES 7.5MM COMPRESSION PLUG IS ALSO USED IN COMBINATION WITH 7.5MM CORTEX DRILL TO COMPRESS CANCELLOUS BONE IN VAULT). ALSO FRACTURE OF FRAGILE POROUS GLENOID RIM MIGHT HAVE BEEN CAUSED DUE TO APPLICATION OF HIGH PRESSURE WHILE USING 7.5MM DRILL. HOWEVER, EXACT CAUSE CANNOT BE DEFINITIVELY DETERMINED. EVALUATION: NO PRODUCT OR X-RAYS WERE RETURNED FOR EVALUATION. DEVICE HISTORY RECORDS INDICATE MANUFACTURE TO SPECIFICATION.

    Description of Event or Problem · 1

    IT IS REPORTED THAT SURGEON, WHILE ATTEMPTING TO PREPARE GLENOID TO RECEIVE BASEPLATE IMPLANT, INCURRED A FRACTURE OF THE GLENOID RIM WHICH PRECLUDED HIM FROM USING A TM REVERSE SHOULDER GLENOID BASEPLATE. SURGEON BELIEVES THAT BONE WAS SO OSTEOPOROTIC THAT, WHEN REAMER ENCOUNTERED SCLEROTIC RIM BONE, THAT IT GRABBED AND FRACTURE RESULTED. ALSO, THE 7.5 DRILL DID NOT SEEM SHARP ENOUGH TO REAM INTO THE GLENOID VAULT. THE DRILL CONTINUED TO FRACURE GLENOID RIM AS THE SURGEON ATTEMPTED TO APPLY SUFFICIENT PRESSURE TO DRILL THE GLENOSHPERE BASE PLATE POST. SURGEON FEELS HE COULD HAVE USED THE BASEPLATE UP TO THE POINT THAT THE GLENOID WAS COMPROMISED BY THE 7.5 DRILL. SURGEON UNABLE TO ADEQUATELY SEAT GLENOID BASEPLATE AND ACHIEVE FIXATION, UTILIZED A LARGE HUMERAL HEAD WHICH HE FELT PROVIDED HIM WITH SUFFICIENT STABILITY AND MOTION FOR THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRABECULAR METAL REVERSE SHOULDER SYSTEM INSTRUMENTATION BAS SHOULDER INSTRUMENT LXH ZIMMER, INC. NA 60545326

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R