BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L

    MDR report key: 18904426 · Received March 14, 2024

    Report

    Report Number
    3005180920-2024-00094
    Event Type
    Injury
    Date Received
    March 14, 2024
    Date of Event
    February 14, 2024
    Report Date
    March 14, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826535
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 15 FEBRUARY 2024. LOT 2114934: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-DEC-2021. EXPIRATION DATE: 2026-12-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL ITEMS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 15 FEBRUARY 2024. GMK-SPHERE 02.12.0005L FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 L (K1214169) LOT. 2112010 LOT 2112010: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-DEC-2021. EXPIRATION DATE: 2026-11-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-SPHERE 02.07.1204L TIBIAL TRAY FIXED CEMENTED SIZE 4 L (K090988) LOT. 2114765. LOT 2114765: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-JAN-2022. EXPIRATION DATE: 2027-01-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    KNEE REVISION SURGERY ON THE LEFT SIDE PERFORMED AT ABOUT 1 YEAR 11 MONTHS AFTER THE PRIMARY. LIGAMENTAL INSTABILITY ON THE INTERNAL PART AND PATIENT DISSATISFACTION WITH PAIN SINCE THE PRIMARY SURGERY. LOOSENING OF THE FEMORAL COMPONENT FOUND DURING THE REVISION SURGERY, NO LOOSENING OF THE TIBIAL PLATE. NO INFECTION. EXPLANTATION OF ALL THE COMPONENTS AND IMPLANTATION OF COMPETITOR REVISION IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1969633 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 2114934 07630030826535

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention