BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK-HINGE HINGE POST EXTENSION 20 MM -TINBN COATED

    MDR report key: 20167518 · Received September 9, 2024

    Report

    Report Number
    3005180920-2024-00725
    Event Type
    Malfunction
    Date Received
    September 9, 2024
    Date of Event
    July 29, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630971258525
    PMA / PMN Number
    K210010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW OF THE LOTS INVOLVED IN THE MIX-UP (NOT CONFIRMED) PERFORMED ON 28-AUG-2024 GMK-HINGE 02.09.HE20 GMK-HINGE HINGE POST EXTENSION 20 MM -TINBN COATED LOT 2300554: 10 ITEMS MANUFACTURED AND RELEASED ON 22-MAR-2023. EXPIRATION DATE: 2028-03-05. TO DATE, 03 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ONE PIECE OF THE LOT 2300554 WAS RE-PACKED ON DECEMBER 1ST 2023 GMK-REVISION 02.07.SCP17 TINBN COATED SC PEG - 17MM (K210010) LOT 2306515: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-MAY-2023. EXPIRATION DATE: 2028-04-15. TO DATE, 10 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ONE PIECE OF THE LOT 2306515 WAS RE-PACKED ON DECEMBER 1ST 2023 ANALYSIS PERFORMED BY WASHING AND PACKAGING MANAGER: THE TWO BATCHES WERE PACKED IN TWO COMPLETELY DIFFERENT DATES. THE MIX -UP CANNOT BE TRACED IN THE PRIMARY PROCESS: - LOT 2300554 CLEANING ROOM PACKAGING 07-MAR-2023 - LOT 2306515 CLEANING ROOM PACKAGING 18-APR-2023 BUT ON THE 1ST OF DECEMBER 2023 1 PIECE OF THE LOT 2300554 AND 1 PIECE OF THE LOT 2306515 WERE REPACKAGED. THE SCANS OF THE REPACKAGES SHOW THAT THE RECONCILIATION OF THE LABELS WAS PERFORMED CORRECTLY AS PER PROCEDURE. THIS DOES NOT EXCLUDE AT ALL THE ERROR AT THIS STAGE BECAUSE MAYBE THE OPERATOR HAVE BIPPED THE BARCODES BEFORE PHAVE PACKED THE PIECES AND MIXED-UP THEM IN THE NEXT STEP. THE PROCEDURE ALSO REQUIRES HAVING ONLY ONE BATCH ON THE WORKBENCH. THE IMPORTANT POINT IS THAT ALL AVAILABLE PIECES OF THE LOT 2306515, THAT WERE UNDER MEDACTA CONTROL, HAVE BEEN CHECKED AND NO ISSUE HAS BEEN FOUND SO THE MIX-UP WAS NOT CONFIRMED. 6 PIECES CHECKED AND EVERYTHING IS OKAY, 3 ALREADY IMPLANTED, 1 WAS ALREADY DISCARDED (DUE TO DIFFERENT DATE OF SHIPMENT AND RECEIPT CANNOT BE THE MIXED ONES).

    Description of Event or Problem · 0

    DURING THE PRIMARY KNEE SURGERY, WHEN THE SALES REP OPENED THE PEG FOR THE POLY INSERT (2306515), IT WAS OBSERVED THAT A 20 MM POST WAS IN THE IMPLANT BOX (2300554). THE SURGEON USED A DIFFERENT SIZE TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538321 GMK-HINGE HINGE POST EXTENSION 20 MM -TINBN COATED KNEE POST EXTENSION JWH MEDACTA INTERNATIONAL SA 2300554 07630971258525

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other