BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 2 R

    MDR report key: 16094456 · Received January 4, 2023

    Report

    Report Number
    3005180920-2022-00987
    Event Type
    Injury
    Date Received
    January 4, 2023
    Date of Event
    December 15, 2022
    Report Date
    January 4, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825804
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 20-DEC-2022. LOT 2001645: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-MAY-2020. EXPIRATION DATE: 2025-04-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. ADDITIONAL COMPONENTS INVOLVED IN THE EVENT: GMK-SPHERE 02.07.1201R TIBIAL TRAY FIXED CEMENTED SIZE 1 R (K090988) LOT. 1908609: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-APR-2020. EXPIRATION DATE: 2025-03-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. GMK-SPHERE 02.12.0112FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 1/12 MM R (K121416) LOT. 1910184: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-DEC-2019. EXPIRATION DATE: 2024-12-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 1 YEAR AND 11 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING KNEE INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1177272 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 2 R KNEE FEMORAL COMPONENT CEMENTED JWH MEDACTA INTERNATIONAL SA 02.12.0002R 2001645 07630030825804

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention