BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CMD 24-1059 PROMADE ELBOW

    MDR report key: 23693207 · Received December 2, 2025

    Report

    Report Number
    3008021110-2025-00152
    Event Type
    Injury
    Date Received
    December 2, 2025
    Date of Event
    November 3, 2025
    Report Date
    December 2, 2025
    Manufacturer
    LIMACORPORATE S.P.A
    Product Code
    JDC
    UDI-DI
    08033390279871
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS OF MANUFACTURING AND STERILIZATION RECORDS DID NOT IDENTIFY ANY PRE-EXISTING ANOMALY OR NONCONFORMITY ON THE INVOLVED HUMERAL STEM AND ITS ASSOCIATED COMPONENTS, INDICATING THAT THE IMPLANT HAS BEEN RELEASED ACCORDING TO CASE REPORT APPROVED BY SURGEON. FROM FOLLOW-UP COMMUNICATION WITH SALES REPRESENTATIVE IT WAS LEARNED THAT THE PATIENT LIVES IN SAUDI ARABIA. LAST X-RAYS WERE TAKEN IN (B)(6) 2025 AND MEDICAL TEAM CLEARED HIM TO RETURN HOME. PATIENT WAS SUPPOSED TO FOLLOW UP IN THE US IN (B)(6) 2025 BUT DIDN'T ARRIVE UNTIL SEPTEMBER. DURING FOLLOW-UP VISIT THE PATIENT WAS WEARING A SPLINT BUT HAS REPORTED NO PAIN. NEW CASE REPORT REQUEST FOR CUSTOM IMPLANTS HAS BEEN OPENED UNDER REFERENCE (B)(4), BUT THE REVISION SURGERY HAS NOT BEEN SCHEDULED YET. THE MANUFACTURER WILL SUBMIT A FINAL REPORT AS SOON AS THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    UPCOMING ELBOW REVISION SURGERY DUE TO LOOSENING OF THE HUMERAL STEM DISCOVERED IN EARLY NOVEMBER 2025. CUSTOM IMPLANT FAILURE HAS BEEN REPORTED FOR CMD 24-1059: THE HUMERAL STEM BECAME LOOSE. PATIENT REPORTED THEY DID NOT FALL, THUS EXCLUDING THIS AS CAUSE OF THE INCIDENT. NEW CUSTOM IMPLANTS HAVE BEEN REQUESTED FOR THE HUMERAL ASSEMBLY, CURRENTLY CONSISTING OF: - (B)(4) HUMERAL STEM (PART NUMBER 9617.25.31T, LOT NUMBER 2416121, STERILIZATION 2400129), - (B)(4) HUMERAL IMPLANT (PART NUMBER 9617.P9.004, LOT NUMBER 2416371, STERILIZATION 2400141), - (B)(4) RADIAL STEM (PART NUMBER 9617.25.31U, LOT NUMBER 2421076, STERILIZATION 2400163), - (B)(4) RADIAL AUGMENT (PART NUMBER 9618.14.15J, LOT NUMBER 2416120, STERILIZATION 2400129). PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2024. PATIENT IS MALE, YEAR OF BIRTH IS 1959. EVENT OCCURRED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1864524 CMD 24-1059 PROMADE ELBOW CMD 24-1059 HUMERAL STEM JDC LIMACORPORATE S.P.A 9617.25.31T 2416121 08033390279871

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other