BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CMD 24-1186 HUMERAL STEM

    MDR report key: 20035347 · Received August 22, 2024

    Report

    Report Number
    3008021110-2024-00068
    Event Type
    Injury
    Date Received
    August 22, 2024
    Date of Event
    July 15, 2024
    Report Date
    October 25, 2024
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    JDC
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: CHECKING THE MANUFACTURING CHARTS OF THE CMD 24-1186 HUMERAL STEM (PART CODE 9617.25.31Z, LOT NUMBER: 2416472, STERILIZATION 2400137), NO PRE-EXISTING ANOMALY HAS BEEN DISCOVERED. BOTH THE COMPONENTS INVOLVED IN THE SWAPPING HAVE BEEN SENT BACK TO THE MANUFACTURER. ACCORDING TO THE INTERNAL INVESTIGATION, THE SWAPPING OF THE COMPONENTS HAPPENED IN THE MANUFACTURING PROCESS, IN PARTICULAR THE ROOT CAUSES IDENTIFIED ARE THE FOLLOWING: THE NECESSITY TO SEPARATE THE PHYSICAL DEVICE FROM THE WORK ORDER LED TO A WRONG RECOMBINATION OF THE TWO. A CONTROL AFTER PACKAGING IS NOT INCLUDED IN THE WORK ORDER, LEADING TO THE IMPOSSIBILITY TO DETECT A SWAPPING IF THIS HAPPENS IN CLEAN ROOM. THEREFORE, A SPECIFIC CORRECTIVE ACTION WAS PUT IN PLACE, WITH THE AIM OF: PROVIDING THE SURGEON REQUESTING CMD 24-1186 WITH A NEW IMPLANT (PART CODE 9617.25.31Z, LOT NUMBER: 2421328, STERILIZATION 2400168). PROVIDING THE SURGEON REQUESTING CMD 24-1059 WITH A NEW IMPLANT (PART CODE 9617.25.31U, LOT NUMBER: 2421076, STERILIZATION 2400163). IMPROVING THE INTERNAL PROCEDURE TO DETECT ANY SWAPPING THAT MAY HAPPEN IN THE CLEAN ROOM PROVIDING TRAINING TO THE OPERATORS. ACCORDING TO THE INFORMATION RECEIVED, THE NEW COMPONENTS HAVE BEEN SUCCESSFULLY IMPLANTED IN AUGUST, AND BOTH THE SURGEONS WERE SATISFIED. PMS DATA: ACCORDING TO THE RELEVANT PMS DATA, THIS IS THE FIRST AND ONLY COMPLAINT THAT WE HAVE REGISTERED ON THE SWAPPING OF TWO CUSTOM MADE IMPLANTS. AS DESCRIBED ABOVE, A CAPA PLAN HAS BEEN ALREADY PUT IN PLACE BY THE COMPANY. THE CORRECTIVE ACTION IS CURRENTLY CLOSED. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE. NOTE: THIS IS A FINAL MDR.

    Additional Manufacturer Narrative · 0

    CHECKING THE MANUFACTURING CHARTS OF THE CMD 24-1186 HUMERAL STEM (PART CODE 9617.25.31Z, LOT NUMBER 2416472, STERILIZATION (B)(4)), NO PRE-EXISTING ANOMALY HAS BEEN DISCOVERED. WE WILL SUBMIT A FINAL REPORT AS SOON AS THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    DURING SURGERY FOR CMD 24-1186 PLANNED ON (B)(6) 2024, THE HUMERAL STEM BOX (LISTING THE PROPER IMPLANT COMMERCIAL CODE 9617.25.31Z, LOT NUMBER: 2416472, STERILIZATION NUMBER: 2400137) WAS OPENED AND CONTAINED THE WRONG DEVICE 9617.25.31U. THE COMPONENT FOUND (PART CODE 9617.25.31U, LOT NUMBER: 2416372, STERILIZATION 2400137) BELONGS TO CASE CMD 24-1059 SCHEDULED ON (B)(6), WAS THEN RE-MANUFACTURED FOR THAT SURGERY. WE WERE ABLE TO CONFIRM THAT THE CORRECT DEVICE FOR CASE CMD 24-1186 (9617.25.31Z) WAS INSIDE THE CMD 24-1059 BOX (9617.25.31U). THE SURGEON OF THE CASE CMD 24-1186 DID NOT PROCEED WITH THE IMPLANTATION OF THE CUSTOMIZED COMPONENT AFTER PREVIOUS HARDWARE REMOVAL AND REQUESTED THE CORRECT DEVICE TO BE DELIVERED TO PROCEED WITH SURGERY. ON (B)(6) 2024, THE PROPER DEVICE WAS DELIVERED TO THE HOSPITAL. THE AGENT THEN OPENED THE IMPLANT TO THE CHECK AND SEE IF IT WAS CORRECT BEFORE SURGERY. IT WAS REPORTED THAT HE ADDED THE IMPLANT TO THE INSTRUMENT TRAY FOR STERILIZATION. THE SURGEON THEN OPENED THE TRAY TO TEST THE DEVICE BEFORE SURGERY. WHEN THE HOSPITAL FOUND OUT ABOUT THIS THE HOSPITAL DECIDED NOT TO ALLOW THE STERILIZATION BECAUSE IT WAS OFF LABEL. THEREFORE, IMPLANT NEEDED TO BE REPRODUCED TO PROCEED WITH THE SURGERY. THIS SITUATION DELAYED THE TREATMENT FOR THE PATIENT BY 3 WEEKS IN WHICH THE PATIENT DID NOT HAVE A FUNCTIONING ELBOW. THE PATIENT IS A MALE, DATE OF BIRTH ON (B)(6) 1965. EVENT HAPPENED IN THE UNITED STATES.

    Description of Event or Problem · 0

    DURING SURGERY FOR CMD 24-1186 PLANNED ON (B)(6) 2024, THE HUMERAL STEM BOX (LISTING THE PROPER IMPLANT COMMERCIAL CODE 9617.25.31Z, LOT NUMBER 2416472, STERILIZATION NUMBER (B)(4)) WAS OPENED AND CONTAINED THE WRONG DEVICE 9617.25.31U. THE COMPONENT FOUND (PART CODE 9617.25.31U, LOT NUMBER 2416372, STERILIZATION (B)(4)) BELONGS TO CASE CMD 24-1059 SCHEDULED ON (B)(6), THAT WILL NOW BE RE-MANUFACTURED FOR THAT SURGERY. WE WERE ABLE TO CONFIRM THAT THE CORRECT DEVICE FOR CASE CMD 24-1186 (9617.25.31Z) IS INSIDE THE CMD 24-1059 BOX (9617.25.31U). THE SURGEON OF THE CASE CMD 24-1186 DIDN'T PROCEED IMPLANTATION AFTER PREVIOUS HARDWARE REMOVAL, AND SHE REQUESTED THAT THE CORRECT DEVICE WAS DELIVERED TO PROCEED WITH SURGERY. ON (B)(6) 2024, THE PROPER DEVICE WAS DELIVERED TO THE HOSPITAL. THE AGENT THEN OPENED THE IMPLANT TO THE CHECK AND SEE IF IT WAS CORRECT BEFORE SURGERY. IT WAS REPORTED THAT HE ADDED THE IMPLANT TO THE INSTRUMENT TRAY FOR STERILIZATION. THE SURGEON THEN OPENED THE TRAY TO TEST THE DEVICE BEFORE SURGERY. WHEN THE HOSPITAL FOUND OUT ABOUT THIS THE HOSPITAL WOULD NOT ALLOW STERILIZATION BECAUSE IT WAS OFF LABEL. THEREFORE, IMPLANT WILL NEED TO BE REPRODUCED IN ORDER TO PROCEED WITH THE SURGERY. THIS WILL DELAY TREATMENT FOR THE PATIENT BY 3 WEEKS IN WHICH THE PATIENT WILL NOT HAVE A FUNCTIONING ELBOW. THE PATIENT IS A MALE, DATE OF BIRTH (B)(6) 1965. EVENT HAPPENED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940178 CMD 24-1186 HUMERAL STEM CMD 24-1186 HUMERAL STEM JDC LIMACORPORATE S.P.A. 9617.25.31Z 2416472

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other