BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 L

    MDR report key: 11064159 · Received December 23, 2020

    Report

    Report Number
    3005180920-2020-00927
    Event Type
    Injury
    Date Received
    December 23, 2020
    Date of Event
    November 22, 2020
    Report Date
    December 23, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819889
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 04 DECEMBER 2020: LOT 1901590: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-JUN-2019. EXPIRATION DATE: 2024-06-05. 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 02.12.0411FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/11 MM L (K140826) LOT. 1900374. BATCH REVIEW PERFORMED ON 04 DECEMBER 2020: LOT 1900374: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-APR-2019. EXPIRATION DATE: 2024-04-10. 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

    1 YEAR AND 3 MONTHS AFTER PRIMARY TKA, THE SURGEON DECIDED TO PERFORM A REVISION SURGERY DUE TO KNEE PAIN AND INSTABILITY. THE PLAN WAS TO CHANGE INSERT ONLY. DURING SURGERY, THE TIBIA WAS FOUND TO BE LOSS AND COMPLETELY DEBONED FROM THE CEMENT. REVISION SURGERY WAS SUCCESSFULLY PERFORMED. LINER AND TIBIAL TRAY REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1527706 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 L TIBIAL BASE FIXED CEMENTED JWH MEDACTA INTERNATIONAL SA 02.07.1203L 1901590 07630030819889

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention