BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/12 MM R

    MDR report key: 13634690 · Received March 1, 2022

    Report

    Report Number
    3005180920-2022-00135
    Event Type
    Injury
    Date Received
    March 1, 2022
    Date of Event
    January 28, 2022
    Report Date
    March 1, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826382
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 07 FEBRUARY 2022. LOT 1900411: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-MAY-2019. EXPIRATION DATE: 2024-APR-15. 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

    THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. ABOUT 2 YEARS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE INSERT WITH A THICKER ONE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2283235 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/12 MM R TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 02.12.0312FR 1900411 07630030826382

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention