BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 20545183 · Received October 28, 2024

    Report

    Report Number
    3005180920-2024-00873
    Event Type
    Injury
    Date Received
    October 28, 2024
    Date of Event
    September 30, 2024
    Report Date
    October 28, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862410
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 07-OCT-2024: LOT 2001675: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-JUN-2020. EXPIRATION DATE: 2025-06-08. 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. ADDITIONAL DEVICE INVOLVED: BATCH REVIEW PERFORMED ON 07-OCT-2024: GMK-SPHERE 02.07.1204L TIBIAL TRAY FIXED CEMENTED SIZE 4 L (K090988) LOT 2002931: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-JUL-2020. EXPIRATION DATE: 2025-07-07. 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.

    Description of Event or Problem · 0

    AT ABOUT 2 YEARS AFTER THE PRIMARY, THE PATIENT HAS BEEN REVISED BECAUSE OF FEMORAL AND TIBIAL COMPONENTS MOBILIZATION. IT WAS REPORTED THAT THE PATIENT STARTED TO EXPERIENCE PROBLEMS IMMEDIATELY AFTER THE PRIMARY. DURING THE REVISION, THE FEMORAL IMPLANT CAME OFF IMMEDIATELY AND A LITTLE AMOUNT OF CEMENT REMAINED ON THE CONDYLE OF THE DEVICE. ALL IMPLANTS HAVE BEEN REVISED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1166845 GMK SPHERE TOTAL KNEE SYSTEM GMK-SPHERE SPHERE FEMUR CEMENTED LEFT S5 + JWH MEDACTA INTERNATIONAL SA 02.12.0025L 2001675 07630030862410

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention