BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER TM REVERSE SHOULDER GLENOSPHERE

    MDR report key: 2120073 · Received June 7, 2011

    Report

    Report Number
    1822565-2011-01314
    Event Type
    Injury
    Date Received
    June 7, 2011
    Date of Event
    May 8, 2011
    Report Date
    May 9, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS REC'D FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. SURGICAL NOTES WERE NOT PROVIDED. X-RAYS WERE NOT PROVIDED; IT IS UNK 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: THE DEVICE HISTORY RECORD HAS BEEN REVIEWED AND THE LOT IN QUESTION WAS PRODUCED, INSPECTED AND PACKAGED WITHIN ESTABLISHED AND VALIDATED PROCESS PARAMETERS. 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 REC'D, 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 DUE TO THE GLENOSPHERE DISASSOCIATING FROM THE BASEPLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER TM REVERSE SHOULDER GLENOSPHERE KWT ZIMMER, INC. 61726105

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention