BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 7914097 · Received September 27, 2018

    Report

    Report Number
    3005180920-2018-00736
    Event Type
    Injury
    Date Received
    September 27, 2018
    Date of Event
    August 30, 2018
    Report Date
    September 27, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030826740
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 24 SEPTEMBER 2018. LOT 170332: 25 ITEMS MANUFACTURED AND RELEASED ON 21 MARCH 2017. EXPIRATION DATE: 2022-03-06 NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 23 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    ABOUT 11 MONTHS AFTER PRIMARY THE SURGEON REVISED THE PATIENT BECAUSE A RIGHT INSERT WAS USED IN A LEFT KNEE AND THE PATIENT COMPLAINED PAIN AND DISCOMFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755921 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM R TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 170332 07630030826740

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention