BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 L

    MDR report key: 19141610 · Received April 19, 2024

    Report

    Report Number
    3005180920-2024-00154
    Event Type
    Malfunction
    Date Received
    April 19, 2024
    Date of Event
    March 22, 2024
    Report Date
    April 19, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825811
    PMA / PMN Number
    K121416
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 04 APRIL 2024: GMK-SPHERE 02.12.0003L FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 L LOT 2349204: 15 ITEMS MANUFACTURED AND RELEASED ON 31-JAN-2024. EXPIRATION DATE: 2029-01-16. OF THIS LOT 7 ITEMS WERE UNDER CONTROL IN A MEDACTA WAREHOUSE. THEY HAVE BEEN IMMEDIATELY OPENED FINDING THE 2 REMAINING MIXED ITEMS (THE THIRD ONE IS THE SUBJECT OF THIS COMPLAINT). GMK-SPHERE 02.12.0003R FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 R LOT 2348382: 15 ITEMS MANUFACTURED AND RELEASED ON 31-JAN-2024. EXPIRATION DATE: 2029-01-16. THE ENTIRE LOT WAS IN MEDACTA INTERNATIONAL WAREHOUSE. ALL PIECES WERE CHECKED CONFIRMING THAT 3 DEVICES OF THIS LOT WERE MIXED UP. IT MEANS THAT 3 DEVICES OF THE LOT 2349204 (SIZE 3L) WERE FOUND IN THE BOXES OF THE LOT 2348382 (SIZE 3R). PRELIMINARY INVESTIGATION PERFORMED BY WASHING AND PACKAGING MANAGER: THE ISSUE PROBABLY OCCURRED WHEN LOADING OR UNLOADING THE IMPLANTS INTO THE BIOWASH, A MACHINE USED FOR CLEANING. BOTH BATCHES INVOLVED ARE COMPOSED BY 15 PIECES, WHILE THE RACKS DEDICATED TO WASH THESE COMPONENTS (FEMUR SIZE 3) HOLD A MAXIMUM OF 12 PIECES. THEREFORE, THE REMAINING 3 PIECES WERE PLACED IN ANOTHER RACK AND DURING THE UNLOADING PHASE, 3 PIECES FOR EACH LOT WERE MIXED-UP. IN ADDITION, DURING THE BATCH INSPECTION, THE OPERATOR DID NOT RECOGNISE THE MIX UP. INTERNAL ACTIONS, INCLUDING TRAINING OPERATORS AND UPDATING WORK INSTRUCTION, HAVE BEEN TAKEN TO PREVENT A REOCCURRENCE OF THE EVENT.

    Description of Event or Problem · 0

    A FEMUR 3R WAS FOUND INSIDE A BOX LABELLED 3L. DURING THE SURGERY, THE SURGEON PUT THE FEMUR WITH CEMENT ON THE PATIENT BONE AND AS SOON AS POSITIONED RECOGNIZED THE ISSUE. A NEW FEMUR WAS OPENED AND IMPLANTED. THE SOFT CEMENT WAS REMOVED FROM BONE AND A NEW LEFT FEMUR WAS IMPLANTED. THERE WERE 10 MINUTES OF DELAY DUE TO THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1081267 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 L KNEE FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 2349204 07630030825811

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Other