BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CMD 24-1157 PROMADE ELBOW

    MDR report key: 21677949 · Received March 24, 2025

    Report

    Report Number
    3008021110-2025-00021
    Event Type
    Injury
    Date Received
    March 24, 2025
    Date of Event
    February 24, 2025
    Report Date
    March 24, 2025
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    JDC
    PMA / PMN Number
    N A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CHECKING THE MANUFACTURING CHARTS OF THE LOT NUMBERS INVOLVED IN THE EVENT, NO PRE-EXISTING ANOMALY WAS DISCOVERED IN THE ITEMS BELONGING THE SAME LOT NUMBERS AS THE COMPONENTS INVOLVED IN THE COMPLAINT. WE WILL SUBMIT A FINAL MDR AS SOON AS THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    ELBOW REVISION SURGERY DUE TO DISLOCATION PERFORMED ON (B)(6) 2025. THE FOLLOWING COMPONENTS WERE INVOLVED IN THE EVENT: ULNAR BODY LARGE RIGHT + SCREW (PART CODE: 1552.14.021, LOT NUMBER: 2228604, STERILIZATION 2300072). ULNAR LINER - LARGE RIGHT (PART CODE: 1560.50.021, LOT NUMBER: 24AT3T6, STERILIZATION 2400221). CMD 24-1157 HUMERAL STEM (PART CODE: 9617.25.31X, LOT NUMBER: 2433650, STERILIZATION 2400265). CMD 24-1157 ULNAR IMPLANT (PART CODE: 9617.25.31Y, LOT NUMBER: 2436134, STERILIZATION 2400278). CMD 24-1157 HUMERAL IMPLANT (PART CODE: 9617.P9.00D, LOT NUMBER: 2433653, STERILIZATION 2400268). THE IMPLANT DISSOCIATED AND WAS PRESSING ON THE HUMERAL SKIN, SO THE SURGEON PERFORMED AN IMPLANT REDUCTION. NO IMPLANTS WERE NEEDED OR USED. THE SURGEON MAY WANT TO LINK WITH AXLE WHEN IT BECOMES AVAILABLE, BUT HE IS NOT SURE AT THIS TIME. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2025. THE EVENT HAPPENED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706935 CMD 24-1157 PROMADE ELBOW CMD 24-1157 HUMERAL BODY JDC LIMACORPORATE S.P.A. 9617.P9.00D 2433653

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other