BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK ZIMMER TM REVERSE SHOULDER

    MDR report key: 4223376 · Received October 29, 2014

    Report

    Report Number
    1822565-2014-01479
    Event Type
    Injury
    Date Received
    October 29, 2014
    Report Date
    September 30, 2014
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS RECEIVED VIA PUBLISHED LITERATURE. EVALUATION SUMMARY: 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. JOINT TENSIONING IS BAED ON THE SURGEON'S CLINICAL EVALUATION DURING THE SURGERY. IT IS UNK HOW THE SURGEON DETERMINED THE REQUIRED JOINT TENSION, AS NO OPERATIVE NOTES WERE RECEIVED. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFO; HOWEVER, NO INFO HAS BEEN RECEIVED TO DATE. THE TM REVERSE SHOULDER SURGICAL TECHNIQUE STATES "THE JOINT SHOULD BE STABLE THROUGHOUT THE RANGE OF MOTION. IF THE CONSTRUCT DISLOCATES, VARYING THICKNESS TRIAL LINERS AND/OR TRIAL SPACERS SHOULD BE USED TO OBTAIN THE PROPER JOINT STABILITY." CAUSE CANNOT BE DEFINITIVELY DETERMINED. EVALUATION: IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE PRODUCT AND/OR LOT NUMBERS WERE UNAVAILABLE. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION TO THE REPORTED PROBLEM. BASED ON THE AVAILABLE INFO, 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.

    Description of Event or Problem · 1

    IT IS REPORTED, THE PT WAS REVISED DUE TO DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692772 UNK ZIMMER TM REVERSE SHOULDER SHOULDER PROSTHESIS HSD ZIMMER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention