BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN TORNIER RESURFACING HEAD

    MDR report key: 15494334 · Received September 27, 2022

    Report

    Report Number
    0001649390-2022-00075
    Event Type
    Injury
    Date Received
    September 27, 2022
    Date of Event
    June 13, 2019
    Report Date
    January 3, 2023
    Manufacturer
    TORNIER S.A.S.
    Product Code
    PHX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. DEVICE DISPOSITION IS UNKNOWN.

    Additional Manufacturer Narrative · 0

    PLEASE NOTE CORRECTIONS IN THE H6 RESULTS CODE, PLEASE NOTE THE REG# AS: MONTBONNOT 3000931034, AND PLEASE NOTE THE CORRECTION OF: D3 MANUFACTURER ENTITY AND G1 MANUFACTURING SITE FOR DEVICES: THE REPORTED EVENT COULD BE CONFIRMED. THE DEVICE WAS NOT RETURNED BUT EVIDENCES WERE PROVIDED, BASED ON PROVIDED X-RAYS AND REPORTED DATA, WHICH MATCHES THE ALLEGED FAILURE. SINCE X-RAYS WERE PROVIDED, THE OPINION OF THE MEDICAL EXPERT WAS REQUESTED AND STATED AS FOLLOWING: "THE X-RAYS OF APRIL 17TH, 2019 (THAT IS 5 YEARS AFTER THE INDEX SURGERY) SHOW A HIGH RIDING HUMERAL HEAD CONTACTING THE ACROMION AND CAUSING SCLEROSIS OF ITS UNDERSURFACE, KNOWN AS ACETABULARIZATION (STARTS TO LOOK LIKE THE SOCKET OF A HIP JOINT). THIS INDICATES GROSS FAILURE OF THE ROTATOR CUFF, HENCE THE IMPLANTATION OF A REVERSED SHOULDER ARTHROPLASTY. THE INDICATION FOR REVISION IS ROTATOR CUFF FAILURE. THE HUMERAL HEAD IMPLANT HAS NOT FAILED ITSELF". THE EVENT DESCRIPTION REPORTED THAT THERE WAS A REVISION SURGERY WITH A REMOVED TORNIER RESURFACING HEAD. X-RAYS REVIEW SHOWED AN ELEVATION OF THE HUMERAL HEAD IN CONTACT WITH THE ACROMION (CONFIRMED ON X-RAYS TAKEN BEFORE THE REVISION SURGERY), DUE TO A ROTATOR CUFF FAILURE WHICH CAUSED THE "FAILED PRIOR ARTHROPLASTY" AND THEREFORE LED TO A REVISION SURGERY. BASED ON THE PROVIDED INFORMATION ABOVE, THE LINK WITH THE DEVICE SEEMS HIGHLY IMPROBABLE. MORE INFORMATION (AS PATIENT CONDITIONS, POST-OPERATIVE TRAUMATISM, SURGERY INFORMATION) IS REQUIRED TO DETERMINE AN EXACT ROOT CAUSE. 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. INDICATIONS OF MATERIAL, MANUFACTURING, OR DESIGN RELATED PROBLEMS WERE UNABLE TO BE IDENTIFIED AS THE CATALOG NUMBER AND LOT NUMBER WERE NOT COMMUNICATED. IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A REVISION SURGERY FOR AN UNKNOWN REASON. THE TORNIER RESURFACING HEAD UNK CATALOG WAS REMOVED AND THE TORNIER INC/TORNIER PROTHESIS WAS IMPLANTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A REVISION SURGERY FOR AN UNKNOWN REASON. THE TORNIER RESURFACING HEAD UNK CATALOG WAS REMOVED AND THE TORNIER INC/TORNIER PROTHESIS WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1885906 UNKNOWN TORNIER RESURFACING HEAD SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX TORNIER S.A.S. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male Required Intervention