BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE SCREW Ø6,5 H.25MM

    MDR report key: 19790165 · Received July 22, 2024

    Report

    Report Number
    3008021110-2024-00061
    Event Type
    Injury
    Date Received
    July 22, 2024
    Report Date
    July 19, 2024
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    MBL
    PMA / PMN Number
    K172456
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION. CHECKING THE MANUFACTURING CHARTS OF THE LOT NUMBERS INVOLVED (1903659 AND 1906270) IN THE COMPLAINT, NO PRE-EXISTING ANOMALY HAS BEEN FOUND OUT. A FINAL MDR WILL BE SUBMITTED AS SOON AS THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY NOT YET PERFORMED, ACCORDING TO THE INFORMATION RECEIVED SO FAR. THE INITIAL SURGERY TOOK PLACE ON JUNE 14TH, 2019, AND ON THE INITIAL OPERATIVE REPORT THERE WAS NO EVIDENCE OF INSTABILITY. DURING THAT SURGERY THE FOLLOWING COMPONENTS WERE IMPLANTED: SMR CEMENTLESS FINNED STEM (PART CODE 1304.15.180, LOT NUMBER 1709615, STERILIZATION NUMBER 1700290). SMR REVERSE HUMERAL BODY (PART CODE 1352.15.010 , LOT NUMBER 1901327, STERILIZATION NUMBER 1900074). SMR REVERSE LINER +6MM D.40MM (PART CODE 1365.50.820, LOT NUMBER 18AT2AP, STERILIZATION NUMBER 1900076). SMR GLENOSPHERE 40MM SMALL-R (PART CODE 1374.09.115, LOT NUMBER 1902940, STERILIZATION NUMBER 1900074). SMR GLENOID PEG TT SMALL-R #M (PART CODE 1375.14.652, LOT NUMBER 1818710, STERILIZATION NUMBER 1900021). SMR GLENOID BASEPLATE SMALL-R (PART CODE 1375.15.605, LOT NUMBER 1902177, STERILIZATION NUMBER 1900092). BONE SCREW 6,5 H.25MM (PART CODE 8420.15.020, LOT NUMBERS 1903659 AND 1906270, STERILIZATION NUMBERS 1900109 AND 1900167). IN JUNE 2024, LIMACORPORATE HAS BEEN INFORMED THAT THE SHOULDER IMPLANT SCREWS HAVE BECOME LOOSE AT THE BALL IMPLANT. THE PATIENT IS SCHEDULED FOR SURGERY TO REMOVE THE PRODUCT PREVIOUSLY IMPLANTED AND RECEIVE A NEW DEVICE. THE PATIENT IS A FEMALE, DATE OF BIRTH (B)(6) 1948. THE EVENT HAPPENED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1979702 BONE SCREW Ø6,5 H.25MM CANCELLOUS SCREWS - BONE SCREWS DIA. 6.5 X H. 25 MM MBL LIMACORPORATE S.P.A. 8420.15.020 1903659

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention