BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM GLENOSPHERE

    MDR report key: 1162215 · Received September 3, 2008

    Report

    Report Number
    1822565-2008-00576
    Event Type
    Malfunction
    Date Received
    September 3, 2008
    Date of Event
    July 23, 2008
    Report Date
    August 1, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSD
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE GLENOSPHERE NOT SEATING PROPERLY ONTO BASEPLATE MAY BE CAUSED BY SOFT TISSUE, OR BONE TRAPPED AROUND THE BASE PLATE TAPER DURING GLENOSPHERE INSERTION, INSUFFICIENT BONE CLEARANCE AROUND THE BASE PLATE, INTERFERENCE WITH RETRACTORS, ETC. EACH SCENARIO COULD POTENTIALLY CAUSE THE GLENOSPHERE TO NOT COMPLETELY SEAT ON THE BASEPLATE. STRAIGHT-ON EXPOSURE OF THE GLENOID IS NECESSARY FOR BOTH PROPER REAMING AND COMPONENT INSERTION. THE USE OF BASE PLATE REAMER 2 (36MM OR 40MM) IS NEEDED TO REMOVE BONE AROUND THE BASE PLATE TO AVOID IMPINGEMENT WITH THE GLENOSPHERE. CAUSE CANNOT BE DEFINITIVELY DETERMINED. EVALUATION: NO PRODUCT WAS RETURNED. 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 INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. ZIMMER CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE DEVICE WAS IMPLANTED IN 2008. A POST-OP X-RAY REVEALED INCOMPLETE SEATING OF GLENOSPHERE ON BASEPLATE. IMPLANT WAS STABLE AND LOCKED ON AT SURGERY. STABLE ON POST-OPERATIVE SEQUENTIAL X-RAYS WITH NO CHANGE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM GLENOSPHERE SHOULDER PROSTHESIS HSD ZIMMER, INC. NA 60834839

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR