BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 20470211 · Received October 17, 2024

    Report

    Report Number
    3005180920-2024-00826
    Event Type
    Malfunction
    Date Received
    October 17, 2024
    Date of Event
    September 17, 2024
    Report Date
    October 17, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826979
    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 18 SEPTEMBER 2024: LOT 2337090: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-OCT-2023. EXPIRATION DATE: 2028-SEP-23. TO DATE, NO ITEMS HAVE BEEN IMPLANTED. ADDITIONAL IMPLANT INVOLVED, BATCH REVIEW PERFORMED ON 18 SEPTEMBER 2024: GMK-SPHERE 02.12.0611FL GMK-SPHERE TIBIAL INSERT - FLEX S6L - 11 MM (K140826) LOT 2337089: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-OCT-2023. EXPIRATION DATE: 2028-SEP-23. TO DATE, ONE ITEM HAS BEEN IMPLANTED. INVESTIGATION PERFORMED BY WASHING AND PACKAGING MANAGER: A MIX-UP OCCURRED BETWEEN 2 LOTS, 2337090 AND 2337089. IN PREPARATION FOR FINAL PACKAGING AND UPON COMPLETION OF STEP 530 OF THE ROUTE CARDS, WHICH WERE COMPLETED ON 25-SEPT-2023, AN OPERATOR ERROR OCCURRED, CAUSING THE PIECES OF LOT 2337089 TO BE COMBINED WITH THE DOCUMENTATION OF LOT 2337090 (AND VICE VERSA). THIS WAS AN ISOLATED ERROR INVOLVING A FULL AND DIRECT EXCHANGE BETWEEN THESE TWO LOTS, CAUSED BY AN OVERSIGHT IN EXECUTION OF THE PROCEDURE DEFINED FOR THE OPERATION. ANALYSIS OF THE PRODUCTION RECORDS CONFIRMS THIS OCCURRENCE WAS DISTINCT TO THE LOT NUMBERS INVOLVED, WITH A FULL ACCOUNTING OF PRECISELY (B)(4) PIECES FOR EACH LOT. ALL (B)(4) PIECES OF LOT 2337089 WERE PACKAGED WITH THE LABELING OF LOT 2337090, AND ALL (B)(4) PIECES OF LOT 2337090 WERE PACKAGED WITH THE LABELING OF LOT 2337089. THIS RESULTS IN ALL PIECES BEING ACCOUNTED FOR, AND NOT OPPORTUNITY FOR OTHER PIECES OR LOTS TO BE AFFECTED BY THIS OCCURRENCE. CAPA FILE HAS BEEN OPEN TO PREVENT A REOCCURRENCE OF THE EVENT. RECALL WAS PERFORMED TO REMOVE THE ITEMS FROM THE MARKET. US WAS NOT INVOLVED AS NO ITEMS HAD BEEN SHIPPED THERE.

    Description of Event or Problem · 0

    DURING THE SURGERY, A TIBIAL INSERT 6-11MM (REFERENCE 02.12.0611FL LOT 2337089) WAS FOUND INSIDE THE BOX OF A TIBIAL INSERT 6-12MM LABELED 02.12.0612FL LOT 2337090. ANOTHER BOX OF THE SAME LOT 2337090 WAS OPENED, AND THE SAME ISSUE WAS FOUND (THE BOX CONTAINED 02.12.0611FL LOT 2337089). SURGERY COMPLETED WITH A CR 12 MM INSERT (ANOTHER 12MM FLEX INSERT WAS NOT AVAILABLE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1301241 GMK SPHERE TOTAL KNEE SYSTEM TIBIAL INSERT FIXED SPHERE FLEX SIZE 6/12 MM L JWH MEDACTA INTERNATIONAL SA 02.12.0612FL 2337090 07630030826979

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Other