BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 3/10MM

    MDR report key: 12107465 · Received July 2, 2021

    Report

    Report Number
    3005180920-2021-00533
    Event Type
    Injury
    Date Received
    July 2, 2021
    Date of Event
    June 2, 2021
    Report Date
    September 1, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030817069
    PMA / PMN Number
    K090988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INFORMATION THAT THE DEVICE WAS AVAILABLE WAS RECEIVED ON 03-AUGUST-2021 (PREVIOUSLY IT WAS REPORTED THAT THE ITEM WAS NOT AVAILABLE). DEVICE RECEIVED ON 09-AUGUST-2021 AND ANALYZED ON (B)(6) 2021. VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER. INTRA-OP BREAKAGE OF THE SCREW THAT SECURES THE LINER ON THE TIBIA BASEPLATE. THE SCREW BROKE IN 2 PARTS. ONE REMAINED INSIDE THE TIBIAL TRAY ALREADY CEMENTED ON THE BONE WITH NO POSSIBILITY TO BE REMOVED. FOR THAT REASON, THE SURGEON HAD TO REPLACE ALL THE TIBIAL HARDWARE AND REPLACE IT WITH A NEW ONE. ALSO THE FEMORAL COMPONENT WAS REPLACED WITH A NEW ONE. THE SCREW BROKE BECAUSE THE SURGEON USED THE WRONG SCREWDRIVER TO TIGHTEN IT ON THE BASEPLATE. THE CORRECT SCREWDRIVER TO BE USED HAS A TIGHTENING TORQUE LIMITED AT 3,5NM. IT IS THE ONLY SCREWDRIVER AVAILABLE FOR PRIMARY SURGERY. THE USED SCREWDRIVER HAS A LIMIT TIGHTENING TORQUE AT 6NM AND IS USUALLY AVAILABLE FOR REVISION SURGERY (USED TO SECURE LONGER STEMS ON THE COMPONENTS). IT IS NOT KNOWN THE REASON WHY THIS SCREWDRIVER WAS AVAILABLE FOR A PRIMARY PROCEDURE. THE EVENT IS NOT RELATED TO A FAULTY DEVICE.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 09 JUNE 2021: LOT 2002996: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-JULY-2020. EXPIRATION DATE: 2025-07-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    DURING TKA, THE INSERT LOCKING SCREW BROKE IN 2 PARTS. ONE PART WAS IN THE LINER PE AND THE OTHER PART IN THE TIBIAL BASEPLATE. THE SURGEON REMOVED ALL THE PARTS OF TIBIAL COMPONENTS (LINER, TIBIAL BASEPLATE, AND EXTENSION STEM) AND REPLACED THEM WITH SAME SIZE. A 6 NM REVISION SCREWDRIVER HAS BEEN USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1007740 GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 3/10MM FIXED TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.07.0310PSF 2002996 07630030817069

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other