BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LATITUDE ELBOW ANATOMIC HUMERAL SPOOL SZ PETIT+ SIDE DROIT

    MDR report key: 20269150 · Received September 20, 2024

    Report

    Report Number
    0001649390-2024-00548
    Event Type
    Injury
    Date Received
    September 20, 2024
    Date of Event
    August 26, 2024
    Report Date
    December 23, 2024
    Manufacturer
    TORNIER INC
    Product Code
    JDB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: THIS PART (DKY162) IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE WAS CLEARED IN THE UNITED STATES UNDER 510K K171010. THE DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    CORRECTION - PLEASE REFER TO G1 MANUFACTURING SITE FOR DEVICES. THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCES WERE PROVIDED. THE CASE INFORMATION PROVIDED WAS REVIEWED BY THE MEDICAL EXPERT AND THE OPINION WAS STATED AS FOLLOWS: THE PATIENT INITIALLY UNDERWENT OPEN REDUCTION AND INTERNAL FIXATION (ORIF) FOR A DISTAL HUMERAL FRACTURE. UNFORTUNATELY, THE FIXATION FAILED, NECESSITATING A CONVERSION TO A DISTAL HUMERAL LATITUDE EV IMPLANT. BY IMPLANTING ONLY THE HUMERAL COMPONENTS, THE RESULTING CONSTRUCT FUNCTIONED AS AN ELBOW HEMIARTHROPLASTY, REQUIRING THE HUMERAL SPOOL TO ACHIEVE OPTIMAL ARTICULATION WITH THE PATIENT¿S NATIVE ULNAR TROCHLEA AND RADIAL HEAD. IN SOME CASES, THE RADIAL HEAD IS EXCISED, ALTHOUGH IT IS UNCLEAR IF THAT OCCURRED IN THIS INSTANCE. ADDITIONALLY, THE TERM INSTABILITY CAN BE INTERPRETED IN VARIOUS WAYS. WAS IT DUE TO LOSS OF IMPLANT FIXATION, INSUFFICIENT SOFT-TISSUE TENSION, MALPOSITIONING, UNDER SIZING, OR ANOTHER FACTOR? UNFORTUNATELY, WE LACK SUFFICIENT INFORMATION TO DRAW MEANINGFUL CONCLUSIONS ABOUT THIS CASE. 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. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT MUST BE AVAILABLE IN ORDER TO DETERMINE A ROOT CAUSE OF THE COMPLAINT EVENT. IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WAS REVISED DUE TO INSTABILITY ISSUES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WAS REVISED DUE TO INSTABILITY ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1472181 LATITUDE ELBOW ANATOMIC HUMERAL SPOOL SZ PETIT+ SIDE DROIT PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED JDB TORNIER INC 2189BA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention