BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEMA ELBOW

    MDR report key: 23943011 · Received January 2, 2026

    Report

    Report Number
    3008021110-2025-00165
    Event Type
    Injury
    Date Received
    January 2, 2026
    Date of Event
    October 17, 2025
    Report Date
    January 2, 2026
    Manufacturer
    LIMACORPORATE S.P.A
    Product Code
    JDC
    UDI-DI
    08033390140263
    PMA / PMN Number
    K181362
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF MANUFACTURING AND STERILIZATION RECORDS DID NOT IDENTIFY ANY PRE-EXISTING ANOMALY OR NON-CONFORMITY ON INVOLVED BATCH THAT COULD HAVE CONTRIBUTED TO REPORTED ISSUE. THROUGH FOLLOW-UP COMMUNICATION, IT WAS LEARNED THAT THE REVISION SURGERY HAS NOT BEEN PLANNED YET. THE PATIENT WENT TO THE OR FOR AN IRRIGATION AND DEBRIDEMENT DUE TO A DRAINING SINUS AND THE LOOSENING OF HUMERAL STEM WAS DISCOVERED INTRA-OPERATIVELY. ACCORDING TO MEDICAL HISTORY SHARED BY MEDICAL PERSONNEL INVOLVED IN THE CASE, THE PATIENT HAS A HISTORY OF DIABETES AND HYPERTENSION WELL-MANAGED WITH APPROPRIATE THERAPIES, AND SMOKES ONE PACK OF CIGARETTES PER DAY. PATIENT IS A BUSINESSMAN, AND HE ENJOYS PLAYING STEEL DRUMS. THE MANUFACTURER WILL PROVIDE A FINAL REPORT AS SOON AS THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    REVISION SURGERY PERFORMED ON (B)(6) 2025 TO EXPLANT A LOOSE HUMERAL STEM. ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2023 IMPLANTING THE FOLLOWING COMPONENTS: - TEMA HUMERAL STEM #H10 RIGHT (PART NUMBER 15040.14.101, LOT 1816476, STERILIZATION (B)(6)), - TEMA HUMERAL BODY - LARGE RIGHT (PART NUMBER 1550.15.121, LOT 2019808, STERILIZATION (B)(6)), - TEMA ULNAR STEM #U7 (PART NUMBER 1575.14.050, LOT 1906323, STERILIZATION (B)(6)), - TEMA ULNAR BODY LARGE RIGHT (PART NUMBER 1552.14.021, LOT 2225798, STERILIZATION (B)(6)), - TEMA ULNAR LINER LARGE RIGHT (PART NUMBER 1560.50.021, LOT 2018AT1RV, STERILIZATION (B)(6)), - TEMA AXLE LARGE (PART NUMBER 1590.15.020, LOT 2227696, STERILIZATION (B)(6)). ULNAR COMPONENTS WERE REVISED ON (B)(6) 2023, REPLACING THE PRE-EXISTING STEM WITH TEMA ULNAR STEM #U6 (PART NUMBER 1575.14.030, LOT 2100543, STERILIZATION (B)(6)) AND ULNAR BODY, LINER AND AXLE WITH NEW ONES OF THE SAME SIZE. DURING THE LAST SURGERY ON (B)(6) 2025, THE LOOSE HUMERAL STEM HAS BEEN REMOVED AND CUSTOM-MADE DEVICE HAS BEEN REQUESTED DUE TO BONE LOSS AT THE HUMERAL METAPHYSIS. REFERENCE (B)(4) HAS BEEN ASSIGNED TO THE CUSTOM-MADE DEVICE REQUEST. PATIENT IS MALE, DATE OF BIRTH UNKNOWN. THE EVENT OCCURRED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5574 TEMA ELBOW HUMERAL STEM H10 RIGHT JDC LIMACORPORATE S.P.A 1504.14.101 1816476 08033390140263

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention