BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEQUALIS REVERSED GLENOSPHERE 10 DEGREES TILTED 36 MM X 25MM

    MDR report key: 14197158 · Received April 25, 2022

    Report

    Report Number
    3000931034-2022-00208
    Event Type
    Injury
    Date Received
    April 25, 2022
    Date of Event
    March 22, 2019
    Report Date
    June 9, 2022
    Manufacturer
    TORNIER S.A.S.
    Product Code
    KWS
    UDI-DI
    03700386935831
    PMA / PMN Number
    K081059
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # DWD181, 510K # K081059 WAS CLEARED IN THE UNITED STATES. THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE THE INVOLVED DEVICES WERE NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCES WERE PROVIDED. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. A REVIEW OF THE DEVICE HISTORY WAS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE THE INVOLVED DEVICES WERE NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCES WERE PROVIDED. THE ROOT CAUSE COULD NOT BE DETERMINED SPECIFICALLY. THE MEDICAL OPINION OF A MEDICAL EXPERT STATES THAT "THE FACT THAT THE PATIENT DEVELOPED THE ULNAR NEUROPATHY FOUR DAYS AFTER SURGERY, MAKES IT PLAUSIBLE THAT IT WAS CAUSED BY DIRECT PRESSURE ON THE ULNAR NERVE BY THE INTERNAL-ROTATION ORTHOSIS, THAT THE PATIENT WAS WEARING AFTER SURGERY". HOWEVER, MORE INFORMATION IS REQUIRED TO DETERMINE AN EXACT ROOT CAUSE. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD ULNAR NERVE TUNNEL SYNDROME AND SEVERE PAIN POST-OPERATIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD ULNAR NERVE TUNNEL SYNDROME AND SEVERE PAIN POST-OPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198275 AEQUALIS REVERSED GLENOSPHERE 10 DEGREES TILTED 36 MM X 25MM PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS TORNIER S.A.S. DWD181 8427AT019 03700386935831

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other