BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LATITUDE ELBOW ANATOMIC HUMERAL SPOOL SZ PETIT+ SIDE GAUCHE

    MDR report key: 19262444 · Received May 7, 2024

    Report

    Report Number
    0001649390-2024-00226
    Event Type
    Injury
    Date Received
    May 7, 2024
    Date of Event
    April 11, 2024
    Report Date
    July 31, 2024
    Manufacturer
    TORNIER INC
    Product Code
    JDC
    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

    PLEASE NOTE CORRECTIONS TO SECTION D. (PRODUCT LONG DESCRIPTION, CATALOG #, LOT/SERIAL NO., AND GTIN). THE EVENT INVOLVES A DEVICE THAT IS NOT CLEARED FOR SALE IN THE U.S., BUT A SIMILAR DEVICE (DKY222) IS COMMERCIALLY AVAILABLE AND CLEARED UNDER 510K # K100562. THE REPORTED EVENT COULD BE CONFIRMED, BASES ON THE EVALUATION DONE BY HCP ON PROVIDED X-RAY IMAGES. THE DEVICE INSPECTION WAS NOT POSSIBLE AS THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. NO INDICATIONS OF MATERIAL, DESIGN & MANUFACTURING RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. HOWEVER, ON THE AVAILABLE X-RAYS MEDICAL OPINION WAS SOUGHT FROM AN EXPERIENCED INDEPENDENT MEDICAL EXPERT AS BELOW, ¿THE IMAGES SHOW AN INFERIOR SUBLUXATION OF THE HUMERUS IN RELATION TO THE GLENOSPHERE. THIS IS INDEED A SIGN OF INSUFFICIENT SOFT TISSUE TENSION AND JOINT INSTABILITY. OTHER THAN THAT, ALL IMPLANT COMPONENTS ARE INTACT AND THE HUMERAL STEM AND GLENOID BASEPLATE ARE WELL-FIXATED TO THE BONE.¿ BASED ON INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO A PATIENT RELATED ISSUE. THE FAILURE WAS CAUSED DUE TO INSUFFICIENT SOFT TISSUE TENSION. IF DEVICE IS RETURNED OR ANY FURTHER INFORMATION IS PROVIDED, THE INVESTIGATION REPORT WILL BE REASSESSED.

    Additional Manufacturer Narrative · 0

    BASED ON THE AVAILABLE INFORMATION THE DEVICE WILL NOT BE RETURNED THEREFORE AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL.

    Description of Event or Problem · 0

    AS REPORTED: "PATIENT UNDERWENT LEFT DISTAL HUMERAL REPLACEMENT ON (B)(6) 2024, FOR COMMINUTED FRACTURE OF LEFT DISTAL HUMERUS. PATIENT SUSTAINED A FALL THE PREVIOUS WEEK. SURGERY PROCEEDED WELL. NO PRE-OP X-RAYS AVAILABLE. ON (B)(6) 2024, PATIENT FELL AGAIN, RE-FRACTURING HER LEFT DISTAL HUMERUS, AND DISLODGING THE SURGICAL REPAIR. PATIENT HAD REVISION SURGERY, YESTERDAY, PROCEEDED WELL. HUMERAL SPOOL (IMPLANTED LAST WEEK) CHANGED TO ACCOMMODATE A TOTAL ELBOW REPLACEMENT CONSTRUCT (ULNAR COMPONENTS NOW IMPLANTED). THIS SPOOL KEPT BY THE SURGEON. ELBOW JOINT STABLE, AT CONCLUSION OF SURGERY."

    Description of Event or Problem · 0

    AS REPORTED: "PATIENT UNDERWENT LEFT DISTAL HUMERAL REPLACEMENT ON (B)(6) 2024, FOR COMMINUTED FRACTURE OF LEFT DISTAL HUMERUS. PATIENT SUSTAINED A FALL THE PREVIOUS WEEK. SURGERY PROCEEDED WELL. NO PRE-OP X-RAYS AVAILABLE. ON 10 APR 2024, PATIENT FELL AGAIN, RE-FRACTURING HER LEFT DISTAL HUMERUS, AND DISLODGING THE SURGICAL REPAIR. PATIENT HAD REVISION SURGERY, YESTERDAY, PROCEEDED WELL. HUMERAL SPOOL (IMPLANTED LAST WEEK) CHANGED TO ACCOMMODATE A TOTAL ELBOW REPLACEMENT CONSTRUCT (ULNAR COMPONENTS NOW IMPLANTED). THIS SPOOL KEPT BY THE SURGEON. ELBOW JOINT STABLE, AT CONCLUSION OF SURGERY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402045 LATITUDE ELBOW ANATOMIC HUMERAL SPOOL SZ PETIT+ SIDE GAUCHE PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED JDC TORNIER INC 2558AY

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Required Intervention