BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4+ R

    MDR report key: 9792949 · Received March 5, 2020

    Report

    Report Number
    3005180920-2020-00122
    Event Type
    Injury
    Date Received
    March 5, 2020
    Date of Event
    January 4, 2020
    Report Date
    March 5, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862403
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 12 FEBRUARY 2020: LOT 168771: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-FEB-2017. EXPIRATION DATE: 2022-01-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. PRELIMINARY INVESTIGATION PERFORMED BY THE R&D KNEE MANAGER: REVISION SURGERY AFTER 2 YEARS FROM PRIMARY IMPLANTATION DUE TO INFECTION. LOOKING AT THE EXPLANTED COMPONENTS, ANY NON-CONFORMITY CAN BE NOTED. THERE IS NO EVIDENCE THAT THE EVENT IS RELATED TO A FAULTY DEVICE. INFECTION IS A KNOWN POSSIBLE ADVERSE EVENT FOLLOWING TKA'S. ADDITIONAL IMPLANTS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 12 FEBRUARY 2020: GMK-SPHERE 02.12.0410FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM R (K121416). LOT 170327: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-APR-2017. EXPIRATION DATE: 2022-03-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. GMK-SPHERE 02.12.T3I4R TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 R (K121416). LOT 171841: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-JUL-2017. EXPIRATION DATE: 2022-06-29. 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

    REVISION SURGERY DUE TO A SEPSIS 2 YEARS AND 2 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254356 GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4+ R KNEE FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 02.12.0024R 168771 07630030862403

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention