BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 L

    MDR report key: 13151693 · Received January 4, 2022

    Report

    Report Number
    3005180920-2022-00016
    Event Type
    Injury
    Date Received
    January 4, 2022
    Date of Event
    December 17, 2021
    Report Date
    January 4, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819926
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 22 DECEMBER 2021: LOT 2000570: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-APR-2020. EXPIRATION DATE: 2025-MAR-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT. ADDITIONAL DEVICE INVOLVED: BATCH REVIEWS PERFORMED ON 22 DECEMBER 2021: GMK-SPHERE 02.12.0511FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/11 MM L (K140826) LOT 189014: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-FEB-2019. EXPIRATION DATE: 2024-FEB-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT. GMK-SPHERE 02.12.0005L FEMORAL COMPONENT SPHERE CEMENTED SIZE 5 L (K121416) LOT 1909461: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-FEB-2020. EXPIRATION DATE: 2025-FEB-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 1 YEAR AND 2 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REMOVED ALL IMPLANTS, PERFORMED A WASHOUT, AND THEN RE-IMPLANTED THE PATIENT WITH PERMANENT HARDWARE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512626 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 5 L KNEE TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 02.07.1205L 2000570 07630030819926

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention