BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE SPHERE FEMUR CEMENTED RIGHT S6

    MDR report key: 12024588 · Received June 18, 2021

    Report

    Report Number
    3005180920-2021-00500
    Event Type
    Injury
    Date Received
    June 18, 2021
    Date of Event
    May 20, 2021
    Report Date
    June 18, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030825880
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 31-MAY-2021. LOT 1811361: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-APR-2019. EXPIRATION DATE: 2024-03-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL DEVICES INVOLVED BATCH REVIEW PERFORMED ON 31-MAY-2021. GMK-SPHERE 02.07.1205R TIBIAL TRAY FIXED CEMENTED # 5 R (K090988) LOT 1900540: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-MAY-2019. EXPIRATION DATE: 2024-05-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. GMK-SPHERE 02.12.0511FR TIBIAL INSERT FIXED SPHERE FLEX #5/11 MM R (K140826) LOT 186080: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-NOV-2018. EXPIRATION DATE: 2023-11-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING MID-FLEXION INSTABILITY 1 YEAR AND 9 MONTHS AFTER THE PRIMARY SURGERY. THE SURGEON REVISED ALL IMPLANTS AND CONVERTED THE PATIENT FROM A SPHERE KNEE TO A HINGE KNEE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    921352 GMK-SPHERE SPHERE FEMUR CEMENTED RIGHT S6 CEMENTED FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 02.12.0006R 1811361 07630030825880

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention