BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4

    MDR report key: 11054771 · Received December 22, 2020

    Report

    Report Number
    3005180920-2020-00959
    Event Type
    Injury
    Date Received
    December 22, 2020
    Date of Event
    November 30, 2020
    Report Date
    December 22, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819919
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 11 DECEMBER 2020: LOT 1907840: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-MAR-2020. EXPIRATION DATE: 2025-02-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: GMK-SPHERE 02.12.0410FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM R (K121416) LOT. 1910196. BATCH REVIEW PERFORMED ON 11 DECEMBER 2020: LOT 1910196: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-JAN-2020. EXPIRATION DATE: 2024-12-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: GMK-SPHERE 02.12.0006R FEMORAL COMPONENT SPHERE CEMENTED SIZE 6 R (K121416) LOT. 1907921. BATCH REVIEW PERFORMED ON 11 DECEMBER 2020: LOT 1907921: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-NOV-2019. EXPIRATION DATE: 2024-10-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: GMK-SPHERE 02.07.0034RP PATELLA RESURFACING SIZE 2 (K090988) LOT. 1910553. BATCH REVIEW PERFORMED ON 11 DECEMBER 2020: LOT 1910553: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-FEB-2020. EXPIRATION DATE: 2025-01-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN AFTER 4 MONTHS FROM THE PRIMARY SURGERY DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1522087 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 CEMENTED KNEE TIBIAL TRAY JWH MEDACTA INTERNATIONAL SA 02.07.1204R 1907840 07630030819919

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention