BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE TOTAL KNEE SYSTEM

    MDR report key: 20555190 · Received October 29, 2024

    Report

    Report Number
    3005180920-2024-00870
    Event Type
    Injury
    Date Received
    October 29, 2024
    Date of Event
    September 30, 2024
    Report Date
    October 29, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825842
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 07 OCTOBER 2024. LOT: 1910662: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-MAR-2020. EXPIRATION DATE: 2025-03-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL COMPONENT INVOLVED IN THE EVENT: BATCH REVIEW PERFORMED ON 07 OCTOBER 2024. GMK-SPHERE 02.12.0414FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/14 MM R (K121416) LOT: 175261: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-DEC-2017. EXPIRATION DATE: 2022-11-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 18 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING LAXITY OF THE KNEE AND THE CAUSE IS UNKNOWN. AT ABOUT 4 YEARS AND 2 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE FEMUR (WITH A POSTERIOR STABILIZED REVISION FEMORAL COMPONENT) AND INSERT (FROM 14MM TO 17MM AND SEMI CONSTRAINED). THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    929623 GMK SPHERE TOTAL KNEE SYSTEM KNEE FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 02.12.0004R 1910662 07630030825842

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention