BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM

    MDR report key: 10746077 · Received October 28, 2020

    Report

    Report Number
    3005180920-2020-00743
    Event Type
    Injury
    Date Received
    October 28, 2020
    Date of Event
    September 29, 2020
    Report Date
    October 28, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826337
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 9 OCTOBER 2020: LOT 1810371: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-MAY-2019. EXPIRATION DATE: 2024-02-21. 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 DEVICES INVOLVED: BATCH REVIEWS PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 9 OCTOBER 2020: GMK-SPHERE 02.12.0023L FEMORAL COMPONENT SPHERE CEMENTED # 3+ L (K140826) LOT 1810112: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 5-MAY-2019. EXPIRATION DATE: 2024-02-21. 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. GMK-SPHERE 02.12.T4I3L TIBIAL TRAY FIXED CEMENTED # T4-I3 L (K121416) LOT 188981: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-FEB-2019. EXPIRATION DATE: 2024-02-05. 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.

    Description of Event or Problem · 1

    THE PATIENT CAME IN 1 YEAR AFTER THE PRIMARY SURGERY DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE FEMORAL COMPONENT, TIBIAL TRAY, AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1212977 TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0310FL 1810371 07630030826337

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention