BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/11 MM R

    MDR report key: 11830863 · Received May 17, 2021

    Report

    Report Number
    3005180920-2021-00402
    Event Type
    Injury
    Date Received
    May 17, 2021
    Date of Event
    April 21, 2021
    Report Date
    May 17, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862588
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 23.APRIL.2021: LOT 143226: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-OCT-14. EXPIRATION DATE: 2019-08-31. 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 SINCE 2017.

    Description of Event or Problem · 1

    5 YEARS AND 3 MONTHS AFTER THE PRIMARY SURGERY THE PATIENT CAME IN REPORTING INSTABILITY DUE TO A HYPEREXTENDED KNEE. THE CAUSE OF THE HYPEREXTENDED KNEE IS UNKNOWN. THE SURGEON REVISED THE SPHERE INSERT FLEX RIGHT 11MM S3 WITH A GMK-SPHERE TIBIAL INSERT - FLEX S3R - 17MM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728924 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/11 MM R KNEE FIXED TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0311FR 143226 07630030862588

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention