BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK PRIMARY TOTAL KNEE SYSTEM

    MDR report key: 22394391 · Received July 3, 2025

    Report

    Report Number
    3005180920-2025-00627
    Event Type
    Injury
    Date Received
    July 3, 2025
    Date of Event
    June 2, 2025
    Report Date
    July 3, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030817649
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 17 JUNE 2025: LOT 132304: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05/08/2013. EXPIRATION DATE: 30/06/2018. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY CLINICAL AFFAIRS DEPARTMENT: ABOUT 12 YEARS AFTER PRIMARY CEMENTED TKA, THE INSERT SAFETY SCREW IS FOUND UNSCREWED AT A ROUTINE XRAY CHECK. THE SURGEON THEREFORE REVISED THE INSERT, WHILE THE METAL COMPONENTS WERE SATISFACTORILY STABLE AND WORKING. NO OTHER DAMAGE HAS BEEN REPORTED OR SHOULD BE EXPECTED. SPONTANEOUS SCREW BACK-OUT HAS BEEN REPORTED PREVIOUSLY, AND WAS COMMONLY ASSOCIATED WITH INSUFFICIENT TIGHTENING TORQUE ADMINISTERED AT THE TIME OF INDEX SURGERY. SINCE THE INTRODUCTION OF THE TORQUE LIMITING SCREWDRIVER, THE NUMBER OF OBSERVATIONS, WHICH WAS ALREADY LESS THAN 0.1% OF THE CASES, ALMOST ZEROED. HOWEVER, BACKING OFF AFTER SUCH A LONG TIME IN SITU IS VERY RARE, THOUGH WE DO NOT KNOW WHEN THE EVENT ACTUALLY TOOK PLACE. ROOT CAUSE: THE MOST LIKELY REASON FOR THIS EVENT IS INSUFFICIENT TORQUE APPLIED TO THE SCREW AT INDEX SURGERY. HOWEVER, OTHER FACTORS MAY ALSO HAVE PLAYED A ROLE, BUT NO DETERMINATION CAN BE MADE BASED. THE INVESTIGATION DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE OR SYSTEMIC DEFICIENCY.

    Description of Event or Problem · 0

    THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AND IT WAS OBSERVED THAT THE SCREW FROM THE POLY WAS FLOATING IN THE KNEE. IT IS UNKNOWN HOW THIS OCCURRED. ABOUT 11 YEARS AND 9 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1188122 GMK PRIMARY TOTAL KNEE SYSTEM TIBIAL INSERT PS FIXED 10MM, SIZE 4 JWH MEDACTA INTERNATIONAL SA 02.07.0410PSF 132304 07630030817649

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention