BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/17 MM R

    MDR report key: 11654476 · Received April 13, 2021

    Report

    Report Number
    3005180920-2021-00291
    Event Type
    Injury
    Date Received
    April 13, 2021
    Date of Event
    March 16, 2021
    Report Date
    April 13, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826467
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 26 MARCH 2021. LOT 172816: 30 ITEMS MANUFACTURED AND RELEASED ON 02-AUG-2017. EXPIRATION DATE: 2022-07-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 9 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN 3 YEARS 3 MONTHS AFTER THE PRIMARY REPORTING INSTABILITY DUE TO LAXITY. THE CAUSE OF THE LAXITY IS UNKNOWN. THE SURGEON REVISED THE POLY WITH A HIGHER ONE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551657 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/17 MM R KNEE FIXED TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.12.0317FR 172816 07630030826467

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention