BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER TM REVERSE SHOULDER GLENOSPHERE

    MDR report key: 4252939 · Received November 12, 2014

    Report

    Report Number
    1822565-2014-01560
    Event Type
    Injury
    Date Received
    November 12, 2014
    Report Date
    October 14, 2014
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TM REVERSE SURGICAL TECHNIQUE STATES THAT "IF UNABLE TO VISUALLY CONFIRM AN EVEN, CIRCUMFERENTIAL ENGAGEMENT OF THE GLENOSPHERE TO THE BASE PLATE, CONSIDER THE USE OF A FLUOROSCOPE TO AID IN THE CONFIRMATION. SEATING OF THE GLENOSPHERE TO THE BASE PLATE CAN BE EXAMINED IN THE AXILLARY VIEW OR IN A VIEW PARALLEL TO GLENOID VERSION. THE MEDIAL RIM OF THE GLENOSPHERE SHOULD BE PARALLEL TO THE FACE OF THE BASE PLATE". IT ALSO STATES TO "RECONFIRM UNIFORM ENGAGEMENT BETWEEN THE BASE PLATE AND GLENOSPHERE BY USING A SMALL ANGLED OR 90 DEGREE CLAMP TO ASSESS FOR MALALIGNMENT GAPS ANTERIOR TO POSTERIOR, AS WELL AS INFERIOR TO SUPERIOR". THIS IS PERFORMED AFTER IMPACTING THE GLENOSPHERE ON THE BASE PLATE. DUE TO THE LACK OF OPERATIVE NOTES, IT IS NOT KNOWN IF THESE CHECKS WERE PERFORMED. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFO; HOWEVER, NO INFO HAS BEEN RECEIVED TO DATE. THE SUPPLIED X-RAY IS NOT DATED AND SHOWS THAT THE GLENOSPHERE IS NOT FULLY SEATED. THEREFORE, IT IS UNK IF THE GLENOSPHERE WAS INITIALLY CIRCUMFERENTIALLY SEATED. REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE LOT NUMBERS WERE UNAVAILABLE. 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, INC. CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THE DOCTOR NOTICED THE GLENOSPHERE WAS NOT SITTING FLUSH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729009 ZIMMER TM REVERSE SHOULDER GLENOSPHERE HSD ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other