BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CMD 23-1031 HUMERAL IMPLANT

    MDR report key: 17379924 · Received July 24, 2023

    Report

    Report Number
    3008021110-2023-00082
    Event Type
    Injury
    Date Received
    July 24, 2023
    Date of Event
    May 24, 2023
    Report Date
    July 21, 2023
    Manufacturer
    LIMACORPORATE S.P.A
    Product Code
    JDC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: CHECKING THE STERILIZATION CHARTS OF THE INVOLVED LOT#: 2304782, NO PRE-EXISTING ANOMALY WAS FOUND ON THE DEVICE. THEREFORE, THE PRODUCT WITH THIS LOT# HAS BEEN PROPERLY STERILIZED BEFORE BEING PLACED ON THE MARKET. THE ITEM INVOLVED WAS NOT AVAILABLE TO BE RETURNED TO LIMACORPORATE FOR FURTHER ANALYSIS. NO ADDITIONAL DETAILS WERE AVAILABLE ON THIS POST-OPERATIVE ISSUE, SPECIFICALLY THE CULTURE RESULTS FOR THE YELLOWISH FLUID AND ANY PRE-OPERATIVE OR POST-OPERATIVE X-RAYS RELATED TO THE REVISION SURGERY. BASED ON THE VERY FEW INFORMATION RECEIVED, WE ARE NOT ABLE TO FURTHER INVESTIGATE THE ROOT CAUSE OF THE EVENT. HOWEVER, CONSIDERING THAT THE CHECK OF THE STERILIZATION CHART HIGHLIGHTED NO ANOMALIES ON THE COMPONENT MANUFACTURED WITH THE INVOLVED LOT#, WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA: THE EVENT REPORTED BY COMPLAINT SOURCE IS DISLOCATION OF A CUSTOMIZED HUMERAL IMPLANT. NO REVISION RATE IS TO BE PROVIDED SINCE CUSTOMIZED IMPLANTS ARE MANUFACTURED AS SINGLE PIECES. BASED ON THE ROOT CAUSE ANALYSIS PERFORMED AND THAT THIS IS A CUSTOM-MADE DEVICE, NO CORRECTIVE ACTIONS REQUIRED FOR THIS SPECIFIC CASE. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUES. NOTE: THIS IS A COMBINED INITIAL-FINAL MDR.

    Description of Event or Problem · 0

    ELBOW REVISION SURGERY WAS PERFORMED ON (B)(6) 2023, DUE TO A DISLOCATION. THE SURGEON NOTED AS SOON AS THE JOINT WAS ACCESSED "YELLOWISH FLUID EXTRAVASATED FROM IT" AND CULTURES WERE TAKEN. UNFORTUNATELY, THE SURGEON NOTICED GROSS MOTION BETWEEN THE HUMERAL COMPONENT AND THE HUMERAL BONE. HE EASILY REMOVED THE HUMERAL IMPLANT BY HAND. A NEW HUMERAL COMPONENT WAS NOT PLACED. ON (B)(6) 2023, FOLLOW UP SHOWS THAT THE INCISION IS HEALING WITHOUT SIGNS OF INFECTION. THE SURGEON HAS DETERMINED THAT REVISION SURGERY WITH A NEW PATIENT-MATCHED CEMENTED HUMERAL COMPONENT IS NECESSARY. SUBMITTING A NEW COMPASSIONATE USE REQUEST TO THE AGENCY. COMPONENT EXPLANTED: CUSTOM MADE CMD 23-1031 HUMERAL IMPLANT, COMMERCIAL CODE 961725317, LOT#: 2304782, STER#: 2300052. PATIENT: FEMALE. DATE OF BIRTH: ON (B)(6) 1957. EVENT HAPPENED IN U.S. SURGERY HISTORY: ON (B)(6) 2022: OPEN REDUCTION INTERNAL FIXATION (ORIF) PROCEDURE WAS PERFORMED WHERE THIRD-PARTY PLATING WAS UTILIZED. ON (B)(6) 2023: TOTAL ELBOW REPLACEMENT USING LIMACORPORATE TEMA DEVICE WITH COMPASSIONATE USE CMD 23-1031 HUMERAL IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598775 CMD 23-1031 HUMERAL IMPLANT CMD 23-1031 HUMERAL IMPLANT JDC LIMACORPORATE S.P.A 9617.25.317 2304782

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Required Intervention