BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 L

    MDR report key: 14191915 · Received April 25, 2022

    Report

    Report Number
    3005180920-2022-00306
    Event Type
    Injury
    Date Received
    April 25, 2022
    Date of Event
    March 30, 2022
    Report Date
    April 25, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825859
    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 04 APRIL 2022: LOT 181852: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-JUN-2018. EXPIRATION DATE: 2023-06-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL DEVICES INVOLVED : BATCH REVIEW PERFORMED ON 04 APRIL 2022: GMK-SPHERE 02.07.1204L TIBIAL TRAY FIXED CEMENTED SIZE 4 L (K090988) LOT 1900509: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-MAY-2019. EXPIRATION DATE: 2024-05-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING PAIN DUE TO LOOSE IMPLANTS AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS WITH REVISION COMPONENTS 2 YEARS AND 1 MONTH AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO CEMENT ADHERED TO THE IMPLANTS. THE CAUSE OF THIS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171574 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 L KNEE CEMENTED FEMUR JWH MEDACTA INTERNATIONAL SA 02.12.0005L 181852 07630030825859

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention