BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 6/10 MM LEFT

    MDR report key: 6431433 · Received March 24, 2017

    Report

    Report Number
    3005180920-2017-00123
    Event Type
    Injury
    Date Received
    March 24, 2017
    Date of Event
    February 17, 2017
    Report Date
    March 24, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K121416
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 20 MARCH 2017. LOT 123225: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28 NOVEMBER 2012. EXPIRATION DATE: 2017-10-31. 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.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE SURGEON WASHED OUT THE KNEE AND SWAPPED THE POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY. INFECTION WAS SUPERFICIAL. CULTURES ARE NOT AVAILABLE. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214932 GMK-SPHERE TIBIAL INSERT FIXED FLEX SIZE 6/10 MM LEFT TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 123225

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention