BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM L

    MDR report key: 14072203 · Received April 11, 2022

    Report

    Report Number
    3005180920-2022-00248
    Event Type
    Injury
    Date Received
    April 11, 2022
    Date of Event
    March 13, 2022
    Report Date
    April 11, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826139
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 16 MARCH 2022: LOT 163045: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-JULY-2016. EXPIRATION DATE: 2021-JUL-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 1-1-2018.

    Description of Event or Problem · 0

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 5 YEARS AND 1 MONTH POST PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1900394 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/10 MM L KNEE LINER PE JWH MEDACTA INTERNATIONAL SA 02.12.0210FL 163045 07630030826139

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention