BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 2 R

    MDR report key: 13042191 · Received December 20, 2021

    Report

    Report Number
    3005180920-2021-01007
    Event Type
    Injury
    Date Received
    December 20, 2021
    Date of Event
    November 30, 2021
    Report Date
    December 20, 2021
    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 03 DECEMBER 2021. LOT 2000482: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-APR-2020. EXPIRATION DATE: 2025-04-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: GMK-SPHERE 02.12.0310FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM R (K121416) LOT. 2000434. BATCH REVIEW PERFORMED ON 03 DECEMBER 2021. LOT 2000434: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-MARCH-2020. EXPIRATION DATE: 2025-02-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: GMK-SPHERE 02.07.1203R TIBIAL TRAY FIXED CEMENTED SIZE 3 R (K090988) LOT. 2000578. BATCH REVIEW PERFORMED ON 03 DECEMBER 2021. LOT 2000578: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-APR-2020. EXPIRATION DATE: 2025-04-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    AT 1 YEAR AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN IN THE KNEE AND THE CAUSE OF THE PAIN IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS TO COMPETITOR COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1942689 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 2 R CEMENTED FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 02.12.0002R 2000482 07630030825804

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention