BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/17 MM L

    MDR report key: 7662370 · Received July 4, 2018

    Report

    Report Number
    3005180920-2018-00478
    Event Type
    Injury
    Date Received
    July 4, 2018
    Date of Event
    June 26, 2018
    Report Date
    July 4, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826252
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 02 JULY 2018; LOT 163356: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12 SEPTEMBER 2016. EXPIRATION DATE: 29.08.2021. 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. OTHER DEVICE INVOLVED: GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 2 L REFERENCE 02.07.1202L (K090988); LOT 168496: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22 MARCH 2017. EXPIRATION DATE: 2022-03-13; 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

    WE WERE INFORMED ON (B)(4) 2018 THAT THE PATIENT CAME IN COMPLAINING OF INSTABILITY. THE SURGEON BELIEVES THE PATIENT STRETCHED OVER TIME. THE SURGEON PLANS TO REVISE THE POLY ON (B)(6) 2018. ON (B)(6) 2018 WE WERE INFORMED THAT THE SURGEON REVISED THE POLY AND THE TIBIAL COMPONENT ON (B)(6). THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504841 TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/17 MM L TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 163356 07630030826252

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention