BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMERAL STEM #H6 RIGHT

    MDR report key: 15315825 · Received August 29, 2022

    Report

    Report Number
    3008021110-2022-00068
    Event Type
    Injury
    Date Received
    August 29, 2022
    Date of Event
    August 3, 2021
    Report Date
    July 11, 2024
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    JDB
    PMA / PMN Number
    K181362
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRE-EXISTING ANOMALIES BY CHECKING THE DHR OF THE HUMERAL STEM #H6 ON A TOTAL OF (B)(4) STEMS MANUFACTURED WITH THE SAME LOT NUMBER. WE WILL SEND A FINAL MDR ONCE THE INVESTIGATION WILL BE COMPLETED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: CHECKING THE MANUFACTURING CHARTS OF HUMERAL STEM #H6, NO PRE-EXISTING ANOMALY HAS BEEN FOUND ON A TOTAL OF N.5 STEMS MANUFACTURED WITH THE SAME LOT AND STERILIZATION NUMBER. ACCORDING TO OUR RECORDS, AT LEAST 3 OUT OF 5 HUMERAL STEM #H6 WITH LOT 1814676 AND STERILIZATION (B)(4) HAVE BEEN IMPLANTED AND THIS IS THE ONLY COMPLAINT RECEIVED ON THIS LOT NUMBER. NEITHER EXPLANTED COMPONENTS NOR X-RAYS WERE AVAILABLE TO BE RETRIEVED AND ANALYZED. THEREFORE, BASED ON THE FEW INFORMATION AVAILABLE, WE ARE NOT ABLE TO PERFORM ANY FURTHER INVESTIGATION. IT SHOULD BE NOTED THAT, BASED ON THE INFORMATION PROVIDED, THE SURGEON DECIDED TO USE THE IMPLANT OFF-LABEL DURING THE PRIMARY SURGERY (PERFORMED ON (B)(6) 2020). IN FACT, ALTHOUGH THE INSTRUCTIONS FOR USE INDICATE THAT TEMA IMPLANT IS INTENDED FOR CEMENTED USE, THE SURGEON IMPLANTED THE COMPONENTS CEMENTLESS DURING THE PRIMARY SURGERY AND THEREFORE THIS CIRCUMSTANCE SHOULD BE TAKEN INTO ACCOUNT WHEN ANALYSING THE SUBSEQUENT REVISION SURGERIES. HENCE, CONSIDERING THAT: - CHECKING THE MANUFACTURING CHARTS OF HUMERAL STEM #H6, NO PRE-EXISTING ANOMALY HAS BEEN FOUND ON A TOTAL OF N.5 STEMS MANUFACTURED WITH THE SAME LOT AND STERILIZATION NUMBER. - THE SURGEON USED THE IMPLANT OFF-LABEL DURING THE PRIMARY SURGERY. WE CAN CONCLUDE THAT THE EVENT IS NOT PRODUCT RELATED. PMS DATA: AS THE SURGEON CHOSE TO USE THE IMPLANT OFF-LABEL CONSCIOUSLY, NO OCCURRENCE RATE OF SIMILAR EVENTS CAN BE ESTIMATED. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE. NOTE: THIS IS A FINAL MDR.

    Description of Event or Problem · 0

    ELBOW REVISION SURGERY DUE TO UNKNOWN REASON PERFORMED ON (B)(6) 2021. DURING THE INITIAL SURGERY PERFORMED ON (B)(6) 2020 A HUMERAL STEM #H6, ULNAR LINER #SMALL, HUMERAL BODY #SMALL, ULNAR STEM #6 AND A ULNAR BODY #SMALL WERE IMPLANTED. DURING THE REVISION SURGERY HUMERAL STEM #H6 AND HUMERAL BODY - SMALL PREVIOUSLY IMPLANTED WERE REPLACED BY A HUMERAL STEM #H7 AND A HUMERAL BODY # SMALL. 9150414061U00, HUMERAL STEM #H6 RIGHT, LOT 1814676, 1900298. 9155015011U00, HUMERAL BODY SMALL RIGHT+SCREW, LOT 1814787, 1900303. EVENT HAPPENED IN US.

    Description of Event or Problem · 0

    ELBOW REVISION SURGERY DUE TO LOOSENING PERFORMED ON (B)(6) 2021. DURING THE INITIAL SURGERY PERFORMED ON (B)(6) 2020, THE FOLLOWING COMPONENTS WERE IMPLANTED: - HUMERAL STEM #H6 (PART CODE 1504.14.061, LOT 1814676, STERILIZATION (B)(4)) - ULNAR LINER - SMALL (PART CODE 1560.50.011, LOT 18AT1RU, STERILIZATION (B)(4)) - HUMERAL BODY - SMALL (PART CODE 1550.15.011, LOT 1814787, STERILIZATION (B)(4)) - ULNAR STEM #U6 (PART CODE 1575.14.030, LOT 1816847, STERILIZATION (B)(4)) - ULNAR BODY - SMALL (PART CODE 1552.14.011, LOT 2001882, STERILIZATION (B)(4)) DURING THE REVISION SURGERY HUMERAL STEM #H6 AND HUMERAL BODY - SMALL PREVIOUSLY IMPLANTED WERE REPLACED WITH THE FOLLOWING COMPONENTS: - HUMERAL STEM #H7 (PART CODE 1504.14.071, LOT 1813881, STERILIZATION (B)(4)) - HUMERAL BODY - SMALL (PART CODE 1550.15.011, LOT 1814787, STERILIZATION (B)(4)) THE PATIENT'S CLINICAL HISTORY IS THE FOLLOWING: - INITIAL SURGERY PERFORMED ON (B)(6) 2020. - REVISION SURGERY PERFORMED ON (B)(6) 2021, HEREBY REPORTED. - THE COMPONENTS WERE LINKED WITH TEMA AXLE SMALL (PART CODE 1590.15.010) ON SEPTEMBER 10TH, 2021. - REVISION SURGERY PERFORMED ON (B)(6) 2022, DUE TO UNKNOWN REASON. THIS EVENT WAS REGISTERED AS INTERNAL COMPLAINT (B)(4) AND REPORTED TO THE FDA WITH MFR 3008021110-2022-00070. - REVISION SURGERY PERFORMED ON (B)(6) 2022, DUE TO INSTABILITY AND PAIN. THIS EVENT WAS REGISTERED AS INTERNAL COMPLAINT (B)(4) AND REPORTED TO THE FDA WITH MFR 3008021110-2022-00102. THE PATIENT IS A MALE, DATE OF BIRTH (B)(4) 1955, AFFECTED BY POST-TRAUMATIC ARTHRITIS. EVENT HAPPENED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134078 HUMERAL STEM #H6 RIGHT TEMA ELBOW SYSTEM - HUMERAL STEM H6 RIGHT JDB LIMACORPORATE S.P.A. 1504.14.061 1814676

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H