BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/12 MM

    MDR report key: 13547747 · Received February 17, 2022

    Report

    Report Number
    3005180920-2022-00106
    Event Type
    Injury
    Date Received
    February 17, 2022
    Date of Event
    January 18, 2022
    Report Date
    February 17, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826375
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 25 JANUARY 2022. LOT 186015: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-NOV-2018. EXPIRATION DATE: 2023-OCT-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE SIMILAR REPORTED EVENT. ADDITIONAL ITEMS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 25 JANUARY 2022: GMK-SPHERE 02.12.0003L FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 (K121416) L LOT. 2000468 LOT 2000468: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-APR-2020. EXPIRATION DATE: 2025-APR-01. 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 02.07.1203L TIBIAL TRAY FIXED CEMENTED SIZE 3 L (K090988) LOT. 1908619. LOT 1908619: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-APR-2020. EXPIRATION DATE: 2025-MAR-26. 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 02.07.0033RP PATELLA RESURFACING SIZE 1 (K090988) LOT. 2000625. LOT 2000625: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-MAR-2020. EXPIRATION DATE: 2025-FEB-17. 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. AT 1 YEAR AND 4 MONTHS AFTER THE PRIMARY SURGERY, 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
    997980 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/12 MM TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 02.12.0312FL 186015 07630030826375

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention