BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE 02.12.0022R FEMORAL COMPONENT SPHERE CEMENTED SIZE 2+ R

    MDR report key: 14101037 · Received April 13, 2022

    Report

    Report Number
    3005180920-2022-00250
    Event Type
    Injury
    Date Received
    April 13, 2022
    Date of Event
    March 14, 2022
    Report Date
    April 13, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862366
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 24 MARCH 2022: LOT 172753: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-SEPT-2017. EXPIRATION DATE: 2022-09-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 1-1-2018. OTHER DEVICES INVOLVED: BATCH REVIEW PERFORMED ON 24 MARCH 2022: GMK-SPHERE 02.07.1202R TIBIAL TRAY FIXED CEMENTED SIZE 2 R (K090988) LOT 171951: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-JULY-2017. EXPIRATION DATE: 2022-07-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 1-1-2018. GMK-SPHERE 02.12.0211FR TIBIAL INSERT FIXED SPHERE FLEX #2/11 MM R (K140826) LOT 164442: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-OCT-2016. EXPIRATION DATE: 2021-09-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 1-1-2018.

    Description of Event or Problem · 0

    AT 3 YEARS AND 11 MONTHS POST PRIMARY REVISION SURGERY FOR KNEE INSTABILITY. THE REASON OF INSTABILITY IS UNKNOWN. ALL COMPONENTS HAVE BEEN REVISED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2564437 GMK-SPHERE 02.12.0022R FEMORAL COMPONENT SPHERE CEMENTED SIZE 2+ R FEMORAL COMPONENT CEMENTED JWH MEDACTA INTERNATIONAL SA 02.12.0022R 172753 07630030862366

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention