BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 R

    MDR report key: 13504632 · Received February 10, 2022

    Report

    Report Number
    3005180920-2022-00105
    Event Type
    Injury
    Date Received
    February 10, 2022
    Date of Event
    January 18, 2022
    Report Date
    February 10, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819933
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 25 JANUARY 2022: LOT 2100319: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-JUNE-2021. EXPIRATION DATE: 2026-05-31. 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 COMPONENTS INVOLVED: GMK-SPHERE 02.12.0006R FEMORAL COMPONENT SPHERE CEMENTED SIZE 6 R (K121416) LOT. 2105264: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-JUN-2021. EXPIRATION DATE: 2026-05-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-SPHERE 02.12.E0510FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM R E-CROSS (K202022) LOT. 2012401: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-JAN-2021. EXPIRATION DATE: 2026-01-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-SPHERE 02.07.0035RP PATELLA RESURFACING SIZE 3 (K090988) LOT. 2108183: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-SEP-2021. EXPIRATION DATE: 2026-08-30. 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

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 3 MONTHS FROM THE PRIMARY THE SURGEON PERFORMED A WASHOUT, REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59865 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 R KNEE TIBIAL TRAY CEMENTED JWH MEDACTA INTERNATIONAL SA 02.07.1205R 2100319 07630030819933

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention