BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 L

    MDR report key: 14191913 · Received April 25, 2022

    Report

    Report Number
    3005180920-2022-00293
    Event Type
    Injury
    Date Received
    April 25, 2022
    Date of Event
    March 28, 2022
    Report Date
    April 25, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030827136
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 31 MARCH 2022: LOT 2001623: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-JUN-2020. EXPIRATION DATE: 2025-JUN-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT. ADDITIONAL DEVICE INVOLVED. BATCH REVIEW PERFORMED ON 31 MARCH 2022: GMK-SPHERE 02.12.0411FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/11 MM L (K140826) LOT 2002727: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-JUN-2020. EXPIRATION DATE: 2025-JUN-03. 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

    REVISION SURGERY PERFORMED 1 YEAR AND 5 MONTHS AFTER THE PRIMARY SURGERY DUE TO INSTABILITY. DURING THE REVISION SURGERY, THE TIBIA WAS FOUND TO BE LOOSE. TIBIA REVISED AND HIGHER LINER IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171572 GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 L KNEE TIBIAL TRAY CEMENTED JWH MEDACTA INTERNATIONAL SA 02.12.T3I4L 2001623 07630030827136

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Required Intervention