BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER TRABECULAR METAL GLENOSPHERE

    MDR report key: 2251382 · Received September 13, 2011

    Report

    Report Number
    1822565-2011-02065
    Event Type
    Injury
    Date Received
    September 13, 2011
    Date of Event
    August 15, 2011
    Report Date
    August 17, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. EVALUATION SUMMARY: AS RETURNED, THE GLENOSPHERE SHOWS SOME KNICKS AND SCRATCHES MOST LIKELY DUE TO THE REMOVAL OF THE GLENOSPHERE FROM THE PATIENT. SURGICAL NOTES WERE NOT PROVIDED. X-RAYS WERE NOT PROVIDED; IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. THE GLENOSPHERE NOT SEATING PROPERLY ONTO THE BASE PLATE MAY BE CAUSED BY SOFT TISSUE OR BONE TRAPPED AROUND THE BASE PLATE TAPER DURING GLENOSPHERE INSERTION. INSUFFICIENT BONE CLEARANCE AROUND THE BASE PLATE. INTERFACE WITH RETRACTORS, ETC. COULD POTENTIALLY CAUSE THE GLENOSPHERE TO NOT COMPLETELY SEAT ON THE BASE PLATE. STRAIGHT-ON EXPOSURE OF THE GLENOID IS NECESSARY FOR BOTH PROPER REAMING AND COMPONENT INSERTION. HOWEVER AN EXACT CAUSE CANNOT BE DETERMINED WITH CERTAINTY. EVALUATION: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. THE PART MEETS PRINT SPECIFICATION WHERE MEASURED. 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, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT WAS REVISED FOR DISASSOCIATION OF THE GLENOSPHERE FROM THE BASE PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER TRABECULAR METAL GLENOSPHERE KWT ZIMMER, INC. 61608048

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention