BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER TRABECULAR METAL GLENOSPHERE

    MDR report key: 2925021 · Received January 17, 2013

    Report

    Report Number
    1822565-2013-00117
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    December 5, 2012
    Report Date
    December 18, 2012
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: AS RETURNED, THE GLENOSPHERE IS IN GOOD CONDITION WITH MINIMAL WEAR. A WITNESS LINE CAN BE SEEN ON THE INTERNAL TAPER. THIS WITNESS LINE GOES AROUND THE PERIMETER OF THE GLENOSPHERE APPROX 0.20 INCHES FROM THE BOTTOM OF THE TAPER. THIS COULD INDICATE THE GLENOSPHERE DID NOT FULLY SEAT ON THE BASE PLATE. IT IS POSSIBLE THAT DEBRIS IN THE JOINT OR SOFT TISSUE PREVENTED THE GLENOSPHERE TO FULLY SEAT. THE USE OF BASE PLATE REAMER 2, RONGEUR, OR A BUR IS REQUIRED TO REMOVAL ALL REMAINING BONE AND SOFT TISSUE FROM THE BASE PLATE AREA. THE SUPPLIED X-RAY TAKEN THE SAME DAY AS THE INITIAL SURGERY SHOWS A DISASSOCIATED GLENOSPHERE, NO IMMEDIATE POST OPERATIVE X-RAYS WERE PROVIDED TO CONFIRM INITIAL PLACEMENT. CAUSE CANNOT BE DEFINITIVELY DETERMINED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL SUBSTANTIVE INFO BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    THE TM REVERSE SURGICAL TECHNIQUE STATES ON PAGE 14: "IN THE EVENT THAT BASE PLATE REAMER 2 WILL NOT FIT THROUGH THE TISSUE ENVELOPE, THEN ALTERNATIVES INCLUDE USE OF A RONGEUR OR BURR TO CLEAR ANY PERIPHERAL BONE WHICH MAY INHIBIT FULL SEATING OF THE GLENOSPHERE. NOTE: THIS STEP IS NECESSARY TO ENSURE THE GLENOSPHERE HEAD WILL LOCK ON THE BASE PLATE PROPERLY. ALL REASONABLE EFFORTS SHOULD BE MADE TO USE THE APPROPRIATE BASE PLATE REAMER 2. THE SIZE OF BASE PLATE REAMER CORRESPONDS TO THE GLENOSPHERE HEAD TO BE USED." THE PROVIDED OPERATIVE NOTES DO NOT STATE IF BASE PLATE REAMER 2 WAS USED. AS RETURNED THE GLENOSPHERE IS IN GOOD CONDITION WITH MINIMAL WEAR. THE GLENOSPHERE WAS DIMENSIONALLY INSPECTED AND FOUND TO BE CONFORMING WHERE MEASURED. A WITNESS LINE CAN BE SEEN ON THE INTERNAL TAPER. THIS LINE GOES AROUND THE PERIMETER OF THE GLENOSPHERE APPROXIMATELY 0.20 INCHES FROM THE BOTTOM OF THE TAPER. THE LINE ON THE GLENOSPHERE COULD INDICATE THAT IT DID NOT FULLY SEAT ON THE BASE PLATE. IT IS POSSIBLE THAT DEBRIS IN THE JOINT OR SOFT TISSUE PREVENTED THE GLENOSPHERE TO FULLY SEAT. THE BASE PLATE REMAINS IMPLANTED THEREFORE A DETERMINATION ON ITS CONDITION COULD NOT BE MADE. REVIEW OF THE DEVICE HISTORY RECORDS FOR THE GLENOSPHERE AND BASE PLATE DID NOT FIND ANY DEVIATIONS OR ANOMALIES. THE SUPPLIED X-RAY TAKEN THE SAME DAY AS THE INITIAL SURGERY SHOWS A DISASSOCIATED GLENOSPHERE, NO IMMEDIATE POST-OPERATIVE X-RAYS WERE PROVIDED TO CONFIRM INITIAL PLACEMENT. WITH THE PROVIDED INFORMATION AN EXACT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT WAS REVISED DUE TO THE GLENOSPHERE DISASSOCIATING FROM THE BASEPLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26003 ZIMMER TRABECULAR METAL GLENOSPHERE HSD ZIMMER, INC. 62106669

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention