BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LATITUDE ELBOW ULNAR CAP MODEL GRAND

    MDR report key: 23649801 · Received November 25, 2025

    Report

    Report Number
    0001649390-2025-00859
    Event Type
    Injury
    Date Received
    November 25, 2025
    Date of Event
    October 27, 2025
    Report Date
    March 4, 2026
    Manufacturer
    TORNIER INC
    Product Code
    JDB
    UDI-DI
    00846832010929
    PMA / PMN Number
    K171010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION SECTION G MANUFACTURING SITE FOR DEVICES CHANGED FROM WRIGHT MEDICAL CORK (TORNIER ORTHOPEDICS IRELAND LTD) TO TORNIER S.A.S. HEALTH IMPACT CODE CORRECTED FROM DEVICE EXPLANTATION TO DEVICE REVISION. THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION, AND NO OTHER EVIDENCE WERE PROVIDED. THE DEVICE INSPECTION REVEALED THE FOLLOWING: AN EVALUATION OF THE PHOTOGRAPH OF THE EXPLANTED DEVICES PROVIDED BY THE REPORTER INDICATES THAT THE CEMENT MANTLE ON THE IMPLANT STEMS IS INTACT AND PRESENT. ALL SURFACES, POLYMER COMPONENTS, AND FASTENERS ARE PRESENT AND APPEAR TO BE IN SATISFACTORY WORKING CONDITIONS. HOWEVER, NO MEDICAL IMAGING OR PATHOLOGY WAS PROVIDED TO VERIFY THE DYSFUNCTION OF THE IMPLANT OR INFECTION. A FUNCTIONAL AND DIMENSIONAL INSPECTION WAS NOT POSSIBLE SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, DURING MANUFACTURING, FUNCTIONALITY TEST AND DIMENSIONAL INSPECTION WERE DONE ACCORDING TO SPECIFICATIONS. BASED ON INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO A PATIENT FACTORS RELATED ISSUE. AS EXPLAINED BY THE SURGEON WHO PERFORMED THE REVISION IT WAS DECIDED AFTER IN HOUSE PATHOLOGY TESTING AT THE FACILITY AND THE SURGEON'S EVALUATION THE COMPLAINT AGAINST THE DEVICE WAS ATTRIBUTED TO OVERUSE OF THE JOINT BY THE PT CAUSING THE PAIN AND REDUCED ROM. 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. THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, THE PATIENT SUSTAINED A FRACTURED LEFT DISTAL HUMERUS (FOLLOWING A FALL) IN 2017. THIS FRACTURE WAS INTERNALLY FIXED WITH PLATE AND SCREWS, BUT IN 2018, THIS REPAIR FAILED, AND HE UNDERWENT A LEFT TOTAL ELBOW REPLACEMENT ON (B)(6) 2018. THIS PROSTHETIC JOINT HAS PERFORMED WELL, UP UNTIL ABOUT 6 MONTHS AGO, WHEN HE PRESENTED IT TO HIS SURGEON, WITH INCREASING PAIN, AND DECREASED RANGE OF MOTION. SURGEON STATED THAT THERE WERE NO CLINICAL INDICATORS SUGGESTING INFECTION. DURING SURGERY, SIGNIFICANT SYNOVITIS AND DARK COLOURED TISSUE MATERIAL WAS PRESENT IN THE PROSTHETIC JOINT - SURGEON CALLED THIS TISSUE METALOSIS. NO EVIDENCE OF ANY PUS, ETC. AFTER MULTIPLE TISSUE SAMPLES TAKEN, EXTENSIVE DEBRIDEMENT AND LAVAGE, THE SURGEON DECIDED TO REMOVE ALL IMPLANTS, AND INSERT AN ANTIBIOTIC CEMENT SPACER INTO BOTH HUMERAL AND ULNAR CANALS, WITH THE VIEW OF A 2ND STAGE PROCEDURE IN 2-3 MONTHS. NO OTHER INFORMATION AVAILABLE. STAGE 2 PROCEDURE TO BE BOOKED IN THE FUTURE - SURGEON TO ADVISE DATE. 2ND STAGE REVISION PERFORMED ON MONDAY (B)(6) 2025. SURGEON STATED THAT NO INFECTIVE ORGANISM WAS IDENTIFIED FROM SAMPLES TAKEN DURING THE 1ST STAGE OF THIS REVISION. SURGEON BELIEVES THE PROSTHESIS BECAME LOOSE BECAUSE THE PATIENT "OVER-USED" HIS PROSTHETIC ELBOW JOINT, EXCEEDING THE FORCES THAT THE IMPLANT WAS DESIGNED FOR. THE MILD "METALOSIS" - GREY STAINED SYNOVIUM / TISSUE NOTED DURING THE STAGE 1 REVISION, WAS FROM THE LOOSE IMPLANTS BEING ABRAIDED BY THE HARD CEMENT MANTLE. CEMENT SPACER REMOVED, TISSUE SPECIMENS TAKEN, COPIOUS LAVAGE, AND THE NEW PROSTHESIS WERE IMPLANTED, AS PER STANDARD TECHNIQUE. JOINT STABLE ON REDUCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, THE PATIENT SUSTAINED A FRACTURED LEFT DISTAL HUMERUS (FOLLOWING A FALL) IN 2017. THIS FRACTURE WAS INTERNALLY FIXED WITH PLATE AND SCREWS, BUT IN 2018, THIS REPAIR FAILED, AND HE UNDERWENT A LEFT TOTAL ELBOW REPLACEMENT ON (B)(6) 2018. THIS PROSTHETIC JOINT HAS PERFORMED WELL, UP UNTIL ABOUT 6 MONTHS AGO, WHEN HE PRESENTED IT TO HIS SURGEON, WITH INCREASING PAIN, AND DECREASED RANGE OF MOTION. SURGEON STATED THAT THERE WERE NO CLINICAL INDICATORS SUGGESTING INFECTION. DURING SURGERY, SIGNIFICANT SYNOVITIS AND DARK COLOURED TISSUE MATERIAL WAS PRESENT IN THE PROSTHETIC JOINT - SURGEON CALLED THIS TISSUE METALLOSIS. NO EVIDENCE OF ANY PUS, ETC. AFTER MULTIPLE TISSUE SAMPLES TAKEN, EXTENSIVE DEBRIDEMENT AND LAVAGE, THE SURGEON DECIDED TO REMOVE ALL IMPLANTS, AND INSERT AN ANTIBIOTIC CEMENT SPACER INTO BOTH HUMERAL AND ULNAR CANALS, WITH THE VIEW OF A 2ND STAGE PROCEDURE IN 2-3 MONTHS. NO OTHER INFORMATION AVAILABLE. STAGE 2 PROCEDURE TO BE BOOKED IN THE FUTURE - SURGEON TO ADVISE DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2537986 LATITUDE ELBOW ULNAR CAP MODEL GRAND PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED JDB TORNIER INC 9071AT 00846832010929

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention