BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEMA ELBOW

    MDR report key: 23199905 · Received October 2, 2025

    Report

    Report Number
    3008021110-2025-00122
    Event Type
    Injury
    Date Received
    October 2, 2025
    Date of Event
    August 6, 2024
    Report Date
    October 2, 2025
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    JDB
    PMA / PMN Number
    K222807
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION CHECKING THE MANUFACTURING CHARTS OF THE COMPONENTS INVOLVED IN THIS EVENT, NO PRE-EXISTING ANOMALY WAS DISCOVERED IN THE ITEMS BELONGING TO THE LOT NUMBER 2012989 AND STERILIZATION 2000372, AND THE LOT NUMBER 18AT1RU AND STERILIZATION 2000052. THE COMPONENTS REMOVED DURING THE REVISION SURGERY HEREBY REPORTED WERE NOT AVAILABLE TO BE RETURNED FOR FURTHER INVESTIGATION. WE TRIED TO GET ADDITIONAL INFORMATION ABOUT THE EVENT, BUT NO OTHER DATA IS AVAILABLE. HENCE, CONSIDERING THAT: - CHECKING THE MANUFACTURING CHARTS OF THE ULNAR COMPONENTS LOOSE, NO PRE-EXISTING ANOMALIES WERE FOUND IN THE ITEMS BELONGING TO THE SAME LOT NUMBERS AND STERILIZATION NUMBERS. WE DO NOT HAVE ANY EVIDENCE TO CONSIDER THE EVENT AS PRODUCT RELATED. PMS DATA ACCORDING TO THE AVAILABLE PMS DATA, THIS IS THE FIRST CASE OF LOOSENING REGISTERED ON THE COMPONENT WITH CODE 1552.14.011 (THE SECOND AND LAST CASE IS THE NEXT REVISION THAT INVOLVED THE SAME PATIENT, REGISTERED WITH COMPLAINT (B)(4). BASED ON THE ANALYSIS PERFORMED AND ACCORDING TO THE RELEVANT PMS DATA, NO CORRECTIVE ACTIONS IS REQUIRED FOR THIS SPECIFIC CASE. THE MANUFACTURER WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE. NOTE: THIS IS A COMBINED INITIAL-FINAL MDR.

    Description of Event or Problem · 0

    REVISION SURGERY DUE TO ULNAR LOOSENING PERFORMED ON (B)(6) 2024. THE FOLLOWING COMPONENTS WERE REMOVED AND REPLACED BY NEW COMPONENTS: - ULNAR BODY SMALL RIGHT + SCREW (PART CODE 1552.14.011, LOT NUMBER 2012989, STERILIZATION 2000372) - ULNAR LINER SMALL RIGHT (PART CODE 1560.50.011, LOT NUMBER 18AT1RU, STERILIZATION 2000052) - ULNAR STEM #U6.5 (PART CODE 1575.14.040, LOT NUMBER 1819186, STERILIZATION 1900298) PREVIOUS SURGERY PERFORMED ON (B)(6) 2022. THE HUMERAL COMPONENTS IMPLANTED DURING THIS SURGERY REMAINED IN SITU AFTER THE REVISION: - HUMERAL BODY SMALL RIGHT+SCREW (PART CODE 1550.15.011, LOT NUMBER 1814787, STERILIZATION 2000072) - HUMERAL STEM #H7 RIGHT (PART CODE 1504.14.071, LOT NUMBER 2001338, STERILIZATION 2000086) MOREOVER, DURING THE REVISION HEREBY REPORTED, THE PROSTHESIS WAS LINKED WITH THE FOLLOWING COMPONENT: - AXLE #SMALL (PART CODE 1590.15.010, LOT NUMBER 2303175, STERILIZATION 2300054) AFTER THIS FIRST REVISION SURGERY, THE PATIENT UNDERWENT ANOTHER REVISION IN 2025 (REGISTERED BY THE COMPLAINT (B)(4) AND REPORTED TO THE FDA WITH 3008021110-2025-00101). PATIENT IS A MALE, DATE OF BIRTH (B)(6)1962. THE EVENT HAPPENED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2435134 TEMA ELBOW ULNAR BODY SMALL RIGHT JDB LIMACORPORATE S.P.A. 1552.14.011 2012989

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention