BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 2

    MDR report key: 8370491 · Received February 26, 2019

    Report

    Report Number
    3005180920-2019-00095
    Event Type
    Injury
    Date Received
    February 26, 2019
    Date of Event
    January 28, 2019
    Report Date
    February 26, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862366
    PMA / PMN Number
    K140826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 25 FEBRUARY 2019: LOT 181856: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-JUL-2018. EXPIRATION DATE: 2023-05-29. 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. AN ADDITIONAL DEVICE WAS INVOLVED IN THE EVENT: GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 2/13 MM R (K140826), LOT 154383: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-JUL-2015. EXPIRATION DATE: 2020-06-30. 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 COMPLAINING OF PAIN CAUSED BY INSTABILITY 4 MONTHS AFTER PRIMARY SURGERY. THE SURGEON REVISED THE FEMORAL COMPONENT AND THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163650 GMK-SPHERE FEMORAL COMPONENT CEMENTED SIZE 2 KNEE FEMORAL COMPONENT CEMENTED JWH MEDACTA INTERNATIONAL SA 181856 07630030862366

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention