BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CMD 25-1406 PROMADE ELBOW

    MDR report key: 24581688 · Received March 12, 2026

    Report

    Report Number
    3008021110-2026-00135
    Event Type
    Injury
    Date Received
    March 12, 2026
    Date of Event
    January 12, 2026
    Report Date
    March 12, 2026
    Manufacturer
    LIMACORPORATE S.P.A
    Product Code
    JDC
    UDI-DI
    08033390312073
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REVIEW OF MANUFACTURING AND STERILIZATION RECORDS OF INVOLVED COMPONENTS DID NOT HIGHLIGHT ANY PRE-EXISTING ANOMALY OR NON-CONFORMITY RELEVANT TO THE REPORTED ISSUE. THE MANUFACTURER WILL SUBMIT A FINAL REPORT AS SOON AS THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    REVISION SURGERY WAS PERFORMED ON (B)(6) 2026. HUMERAL BODY WITH SAFETY SCREW DISENGAGED FROM MODULAR SPACER. THE PATIENT'S CLINICAL HISTORY IS THE FOLLOWING: THE PATIENT UNDERWENT THE FIRST SURGERY IN 2022 WHEN THE BONE WAS NOTED TO BE SPLINTERED IN MULTIPLE LOCATIONS, AND THE ANATOMY PRESENTED BONE LOSS. THE BONE QUALITY ALSO CAUSED FURTHER FRAGMENTATION DURING THE ORIGINAL FIXATION. POSTOPERATIVELY, THE PATIENT PRESENTED WITH PAIN AND LIMITED MOTION WITH SIGNIFICANT ARTHRITIC CHANGES, THEREFORE UNDERWENT SURGERY TO IMPLANT THE CUSTOM-MADE DEVICE CMD23-1031 (FDA COMPASSIONATE USE REQUEST U230181) ON (B)(6) 2023. THE HUMERAL COMPONENT OF CUSTOM-MADE DEVICE CMD23-1031 WAS REMOVED ON (B)(6) 2023, DUE TO LOOSENING AFTER PHYSICAL THERAPY (THIS REVISION WAS REGISTERED WITH THE CUSTOMER COMPLAINT (B)(4) AND REPORTED TO THE FDA WITH MFR. 3008021110-2023-00082). SUBSEQUENTLY, THE CUSTOM-MADE DEVICE CMD23-1240 (FDA COMPASSIONATE USE REQUEST U230471) WAS IMPLANTED ON (B)(6) 2023 AND REMOVED ON (B)(6) 2024, DUE TO OSTEOLYSIS AROUND HUMERAL STEM (THIS REVISION WAS REGISTERED WITH THE CUSTOMER COMPLAINT (B)(4) AND REPORTED TO THE FDA WITH MFR. 3008021110-2025-00002). AFTER THIS LAST REVISION SURGERY, A NEW CUSTOM-MADE DEVICE WAS REQUESTED (CMD24-1623) BUT LATER WAS CANCELLED AND REPLACED WITH CMD25-1406 AS THE SURGEON WANTED TO RE-DESIGN THE IMPLANT WITH A NEWER CT SCAN. THE SURGERY TO IMPLANT THE CUSTOM-MADE CMD25-1406 WAS SUCCESSFULLY PERFORMED ON (B)(6) 2025 TO IMPLANT THE LINKED CUSTOM TOTAL ELBOW CONSISTING OF FOLLOWING COMPONENTS: HUMERAL STEM CUSTOM (PN: 9617.25.32U, LOT: 2524073, STERILIZATION: 2500156). HUMERAL BODY CUSTOM (PN: 9617.P9.00X, LOT: 2524072, STERILIZATION: 2500159). MODULAR SPACER H30MM (PN: 1314.15.030, LOT: 2401433, STERILIZATION: 2400119). ULNAR LINER LARGE LEFT (PN: 1560.50.020, LOT: 24AT3T5, STERILIZATION: 2400240). AXLE LARGE (PN: 1590.15.020, LOT: 2435933, STERILIZATION: 2500035). DURING HEREBY REPORTED REVISION THE ABOVE-MENTIONED HUMERAL BODY, MODULAR SPACER AND AXLE WERE REMOVED AND A NEW CUSTOM-MADE HUMERAL BODY CMD25-1547 WITH NEW MODULAR SPACER H20MM AND AXLE WERE IMPLANTED. SURGERY WAS COMPLETED AS INTENDED. THE PATIENT IS A FEMALE, DATE OF BIRTH ON (B)(6) 1957. EVENT HAPPENED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638222 CMD 25-1406 PROMADE ELBOW CMD 25-1406 HUMERAL BODY JDC LIMACORPORATE S.P.A 9617.P9.00X 2524072 08033390312073

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention