BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/14 MM R

    MDR report key: 14751542 · Received June 21, 2022

    Report

    Report Number
    3005180920-2022-00475
    Event Type
    Injury
    Date Received
    June 21, 2022
    Date of Event
    May 23, 2022
    Report Date
    June 21, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826429
    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 30 MAY 2022. LOT 161955: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-JUNE-2016. EXPIRATION DATE:2021-06-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT 3 YEARS AND 9 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY AND THE CAUSE OF THE LAXITY IS UNKNOWN. THE SURGEON REVISED THE INSERT (14MM TO 20MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1397011 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/14 MM R KNEE FIXED TIBIAL INSERT PE JWH MEDACTA INTERNATIONAL SA 02.12.0314FR 161955 07630030826429

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention