BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM R

    MDR report key: 16501464 · Received March 8, 2023

    Report

    Report Number
    3005180920-2023-00127
    Event Type
    Injury
    Date Received
    March 8, 2023
    Date of Event
    February 6, 2023
    Report Date
    March 8, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826740
    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 13 FEBRUARY 2023: LOT 180411: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-MAY-2018. EXPIRATION DATE: 2023-04-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY. AT ABOUT 4 YEARS AND 5 MONTHS POST PRIMARY THE SURGEON REVISED THE POLY TO A 2MM THICKER POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1736282 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM R KENE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0510FR 180411 07630030826740

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention