BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMERAL STEM #H9 RIGHT

    MDR report key: 15673934 · Received October 26, 2022

    Report

    Report Number
    3008021110-2022-00102
    Event Type
    Injury
    Date Received
    October 26, 2022
    Date of Event
    September 6, 2022
    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

    CHECKING THE MANUFACTURING CHARTS OF THE INVOLVED LOTS#: 1815327, #2002821, AND #2115522, NO PRE-EXISTING ANOMALY WAS FOUND ON THE COMPONENTS MANUFACTURED WITH THE SAME LOT #S. WE SUBMIT A FINAL MDR AS SOON AS THE INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION CHECKING THE MANUFACTURING CHARTS OF HUMERAL STEM #H9 RIGHT LOT 1815327, NO PRE-EXISTING ANOMALY HAS BEEN FOUND ON A TOTAL OF N.9 STEMS MANUFACTURED WITH THE SAME LOT AND STERILIZATION NUMBER. ACCORDING TO OUR RECORDS, AT LEAST 4 OUT OF 9 HUMERAL STEMS #H9 RIGHT WITH LOT 1815327 AND STERILIZATION 1900181 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 #H9 RIGHT LOT 1815327, NO PRE-EXISTING ANOMALY HAS BEEN FOUND ON A TOTAL OF N.9 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 PERFORMED ON (B)(6) 2022, DUE TO PAIN. ACCORDING TO THE RECEIVED INFORMATION, PATIENT PRESENTED WITH PAIN RELATED TO THE LATERAL ASPECT OF THE HUMERUS ON (B)(6) 2022. THE FOLLOWING COMPONENTS WERE EXPLANTED: HUMERAL STEM #H9 RIGHT (PRODUCT CODE: 1504.14.091, LOT#: 1815327 - STER. 1900181) HUMERAL BODY SMALL RIGHT+SCREW (PRODUCT CODE: 1550.15.011, LOT #2002821 - STER. 2000181). ULNAR BODY SMALL RIGHT + SCREW (PRODUCT CODE: 1552.14.011, LOT#: 2001882 - STER 2000247). ULNAR LINER SMALL RIGHT (PRODUCT CODE: 1560.50.011, LOT#: 18AT1RU - STER. 1900184). ULNAR STEM #U6 (PRODUCT CODE: 1575.14.030, LOT#: 1816847 - STER. 1900298). AXLE #SMALL (PRODUCT CODE: 1590.15.010, LOT#: 2115522 - STER. 2100241). IT WAS REPORTED THAT DURING THE REMOVAL THERE APPEARED TO BE SOME MICROMOTION DISTALLY IN THE HUMERAL STEM, WHILE THE ULNAR IMPLANT WAS WELL FIXED. A COMPETITOR'S PROSTHESIS WAS IMPLANTED. OPERATIVE CULTURES DID NOT SHOW INFECTION. PATIENT IS A MALE, 67 YEARS OLD. HISTORY OF ELBOW SURGERIES IS THE FOLLOWING: DATE OF PRIMARY IMPLANT NOT KNOWN. FIRST REVISION SURGERY PERFORMED ON (B)(6) 2021, TO LINK THE EXISTING IMPLANT WITH AN AXLE. SECOND REVISION SURGERY PERFORMED ON (B)(6) 2022, DUE TO UNKNOWN REASON. THE EVENT IS REGISTERED AS (B)(4) AND REPORTED TO THE FDA BY MFR 3008021110-2022-00070. THIRD REVISION SURGERY PERFORMED ON (B)(6) 2022, DUE TO PAIN (HEREBY REPORTED).

    Description of Event or Problem · 0

    ELBOW REVISION SURGERY PERFORMED ON (B)(6) 2022. DUE TO PAIN. ACCORDING TO THE INFORMATION RECEIVED, PATIENT PRESENTED WITH PAIN RELATED TO THE LATERAL ASPECT OF THE HUMERUS ON (B)(6) 2022. THE FOLLOWING COMPONENTS WERE REMOVED: · HUMERAL STEM #H9 RIGHT (PART CODE 1504.14.091, LOT 1815327, STERILIZATION 1900181), IMPLANTED ON (B)(6) 2022. · HUMERAL BODY SMALL RIGHT+SCREW (PART CODE 1550.15.011, LOT 2002821, STERILIZATION 2000181) IMPLANTED ON (B)(6) 2022. · ULNAR BODY SMALL RIGHT + SCREW (PART CODE 1552.14.011, LOT 2001882, STERILIZATION 2000247), IMPLANTED ON (B)(6) 2020. · ULNAR LINER SMALL RIGHT (PART CODE 1560.50.011, LOT 18AT1RU, STERILIZATION 1900184), IMPLANTED ON (B)(6) 2020. · ULNAR STEM #U6 (PART CODE 1575.14.030, LOT 1816847, STERILIZATION 1900298), IMPLANTED ON (B)(6) 2020. · AXLE #SMALL (PART CODE 1590.15.010, LOT 2115522, STERILIZATION 2100241), IMPLANTED ON (B)(6) 2022. THE COMMERCIAL CODE RELATED TO THE AXLE REMOVED (1590.15.010) IS 510K CLEARED BUT THE SPECIFIC VERSION (002) OF THE PART IS NOT FDA CLEARED. THIS CIRCUMSTANCE WAS DOCUMENTED THROUGH THE INTERNAL COMPLAINT (B)(4) AND REPORTED TO THE FDA WITH MFR 3008021110-2022-00071. THE EVENT IS LINKED TO FIELD ACTION FDA RECALL NUMBER: Z-1261-2023 (LIMACORPORATE REFERENCE 3008021110-01/17/2023-001-C). IT WAS REPORTED THAT DURING THE REMOVAL THERE APPEARED TO BE SOME MICROMOTION DISTALLY IN THE HUMERAL STEM, WHILE THE ULNAR IMPLANT WAS WELL FIXED. A COMPETITOR'S PROSTHESIS WAS IMPLANTED. OPERATIVE CULTURES DID NOT SHOW INFECTION. THE PATIENT'S CLINICAL HISTORY IS THE FOLLOWING: INITIAL SURGERY PERFORMED ON (B)(6) 2020. REVISION SURGERY PERFORMED ON (B)(6) 2021. THIS EVENT WAS REGISTERED AS INTERNAL COMPLAINT (B)(4) AND REPORTED TO THE FDA WITH MFR 3008021110-2022-00068. THE COMPONENTS WERE LINKED WITH TEMA AXLE SMALL (PART CODE 1590.15.010) ON (B)(6) 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 (HEREBY REPORTED). THE PATIENT IS A MALE, DATE OF BIRTH (B)(6) 1955, AFFECTED BY POST-TRAUMATIC ARTHRITIS. EVENT HAPPENED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2802848 HUMERAL STEM #H9 RIGHT TEMA ELBOW SYSTEM - HUMERAL STEM H9 RIGHT JDB LIMACORPORATE S.P.A. 1504.14.091 1815327

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R