BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/17MM

    MDR report key: 11663193 · Received April 14, 2021

    Report

    Report Number
    3005180920-2021-00302
    Event Type
    Injury
    Date Received
    April 14, 2021
    Date of Event
    March 18, 2021
    Report Date
    April 14, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030816833
    PMA / PMN Number
    K103170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 30 MARCH 2021: LOT 131096: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-MAR-2013. EXPIRATION DATE: 2018-01-31. 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 1-JAN-2017.

    Description of Event or Problem · 1

    THE PATIENT HAD A PRIMARY KNEE SURGERY AND WAS IMPLANTED WITH COMPETITOR IMPLANTS. ON (B)(6) 2016, THE PATENT HAD THE COMPETITOR IMPLANTS REVISED TO MEDACTA IMPLANTS AND THE CAUSE OF THE REVISION IS UNKNOWN. 4 YEARS AND 9 MONTHS AFTER MEDACTA PRIMARY THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE INSERT SEMICONSTRAINED 17MM S2 WITH AN INSERT SEMICONSTRAINED 20MM S2 TO GIVE THE PATIENT MORE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563978 GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/17MM KNEE FIXED TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 02.07.0217SCF 131096 07630030816833

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention