BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEMA ELBOW SYSTEM

    MDR report key: 20307678 · Received September 26, 2024

    Report

    Report Number
    3008021110-2024-00073
    Event Type
    Injury
    Date Received
    September 26, 2024
    Date of Event
    July 22, 2024
    Report Date
    February 26, 2026
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    JDB
    UDI-DI
    08033390173230
    PMA / PMN Number
    K222807
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRE-EXISTING ANOMALY HAS BEEN DISCOVERED BY CHECKING THE MANUFACTURING CHARTS OF THE COMPONENTS INVOLVED IN THE EVENT. LIMA CORPORATE WILL SUBMIT A FINAL REPORT AS SOON AS THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    INVESTIGATION NO PRE-EXISTING ANOMALY HAS BEEN DISCOVERED BY CHECKING THE MANUFACTURING CHARTS OF THE COMPONENTS INVOLVED IN THE EVENT. THE MANUFACTURER RECEIVED THE EXPLANTED COMPONENTS, INCLUDED THE AXLE (NOT REPORTED IN THE LIST OF COMPLAINED DEVICES) AND CARRIED OUT AN INTERNAL INVESTIGATION ON THESE DEVICES. INTERNAL ASSESSMENT REVEALED THE AXLE REQUIRED A DISENGAGEMENT TORQUE THAT WAS LIKELY NOT ACHIEVABLE WITH THE INSTRUMENTATION USED AT THE TIME OF THE REVISION SURGERY (SCREWDRIVER BREAKAGE), LEADING TO DEEP DIVE INVESTIGATIONS ON AXLE COMPONENT, UNDERSTANDING THERE WAS A POTENTIAL DIFFERENCE IN MECHANICAL BEHAVIOUR BETWEEN THE 2022 AXLE VALIDATED COMPONENT (REGISTERED AND APPROVED BY FDA AT THAT TIME WITH K222807) AND THE AXLE COMPONENTS ON THE MARKET AT THE TIME OF THE REVISION SURGERY HEREBY REPORTED. THEREFORE, THE MANUFACTURER OPENED A SPECIFIC CORRECTIVE ACTION WITH THE AIM OF: 1) IMPROVING THE AXLE TECHNICAL DRAWING 2) CREATING A NEW SLEEVE TO MITIGATE THE RISK OF BREAKAGE OF THE SCREWDRIVER DURING REVISION SURGERIES 3) MODIFYING THE SURGICAL TECHNIQUE, TO INCLUDE THESE CHANGES 4) RECALLING THE AFFECTED PIECES FROM THE MARKET. FOLLOWING THIS CORRECTIVE ACTION, ALL THE TEMA AXLE SMALL (PART CODE 1590.15.010) AND TEMA AXLE LARGE (PART CODE 1590.15.020) BELONGING TO VERSION 04 (SUCH AS THE ONE INVOLVED IN THIS EVENT) HAVE BEEN RECALLED FROM THE MARKET AND THEY ARE NO LONGER AVAILABLE (REFERENCE 3008021110-11/06/24-001R). THE AXLES VERSION 04 HAVE BEEN REPLACED BY THE NEW VERSION OF THE AXLES, CURRENTLY AVAILABLE, WHICH INCLUDES THE IMPROVEMENTS DESCRIBED IN THE CORRECTIVE ACTION PLAN. THE NEW SLEEVE IS CURRENTLY AVAILABLE AS WELL. PMS DATA CONSIDERING THAT THE REVISION WAS DUE TO LOOSENING OF THE HUMERAL COMPONENT, THIS IS THE SECOND EVENT REGISTERED FOR THIS REASON, THAT INVOLVED A HUMERAL BODY PART CODE 1550.15.111. ADDITIONALLY, TAKING INTO ACCOUNT THAT THE MANUFACTURER RECEIVED ALSO THE TEMA AXLE SMALL IMPLANTED, THAT WAS SUBSEQUENTLY RECALLED, AS DESCRIBED ABOVE, A CAPA PLAN HAS BEEN ALREADY PUT IN PLACE BY THE COMPANY. THE CORRECTIVE ACTION IS CURRENTLY CLOSED. THE MANUFACTURER WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE. NOTE: THIS IS A FINAL MDR.

    Description of Event or Problem · 0

    PATIENT PRESENTED WITH LOOSENING OF HUMERAL COMPONENT AND THE SURGEON REVISED THE IMPLANT ON (B)(6), 2024. DURING THE REVISION THE AXLE BECAME STUCK, AND THE INSTRUMENT USED BROKE. THIS EVENT WAS REGISTERED AS INTERNAL COMPLAINT (B)(4) AND REPORTED TO THE FDA WITH MFR 3008021110-2024-00078. SINCE THE AXLE BECAME STUCK, BOTH ULNAR AND HUMERAL IMPLANT WERE REVISED: - HUMERAL STEM #H8 RIGHT (PART CODE 1504.14.081, LOT NUMBER 1815323, STERILIZATION 1900181) - HUMERAL BODY SMALL RIGHT+SCREW (PART CODE 1550.15.111, LOT NUMBER 2021794, STERILIZATION 2300003) - ULNAR BODY SMALL RIGHT + SCREW (PART CODE 1552.14.011, LOT NUMBER 2225795, STERILIZATION 2300044) - ULNAR LINER SMALL RIGHT (PART CODE 1560.50.011, LOT NUMBER 18AT1RU, STERILIZATION 2000052) - ULNAR STEM #U5.5 (PART CODE 1575.14.020, LOT NUMBER 1811092, STERILIZATION 1900181) PREVIOUS SURGERY TOOK PLACE ON (B)(6), 2023. EVENT HAPPENED IN THE UNITED STATES.

    Description of Event or Problem · 0

    PATIENT PRESENTED WITH LOOSENING OF HUMERAL COMPONENT AND THE SURGEON REVISED THE IMPLANT ON (B)(6) 2024. DURING THE REVISION THE AXLE BECAME STUCK, AND THE INSTRUMENT USED BROKE. THIS EVENT WAS REGISTERED AS INTERNAL COMPLAINT (B)(4) AND REPORTED TO THE FDA WITH MFR. 3008021110-2024-00078. SINCE THE AXLE BECAME STUCK, BOTH ULNAR AND HUMERAL IMPLANT WERE REVISED: HUMERAL STEM #H8 RIGHT (PART CODE 1504.14.081, LOT NUMBER 1815323, STERILIZATION (B)(4) HUMERAL BODY SMALL RIGHT+SCREW (PART CODE 1550.15.111, LOT NUMBER 2021794, STERILIZATION (B)(4) ULNAR BODY SMALL RIGHT + SCREW (PART CODE 1552.14.011, LOT NUMBER 2225795, STERILIZATION (B)(4). ULNAR LINER SMALL RIGHT (PART CODE 1560.50.011, LOT NUMBER 18AT1RU, STERILIZATION (B)(4) ULNAR STEM #U5.5 (PART CODE 1575.14.020, LOT NUMBER 1811092, STERILIZATION (B)(4)) FOR THIS PATIENT, THE SURGEON REQUESTED A CUSTOM DEVICE (CMD (B)(6). PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2023. THE PATIENT IS A FEMALE, DATE OF BIRTH (B)(6) 1951. EVENT HAPPENED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210762 TEMA ELBOW SYSTEM HUMERAL BODY SMALL RIGHT JDB LIMACORPORATE S.P.A. 1550.15.111 2021794 08033390173230

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention