BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/13 MM

    MDR report key: 8478379 · Received April 3, 2019

    Report

    Report Number
    3005180920-2019-00218
    Event Type
    Injury
    Date Received
    April 3, 2019
    Date of Event
    March 4, 2019
    Report Date
    April 3, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030862670
    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 29 MARCH 2019: LOT 141425: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-MAY-2014. EXPIRATION DATE: 2019-03-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4)ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH OTHER TWO SIMILAR REPORTED EVENTS (0221-15 AND 0306-18 [MDR 2018-00188]).

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED AFTER 2 MONTHS FROM THE PRIMARY FOR INFECTION (THE PATHOGEN IS UNKNOWN). THE SURGEON PERFORMED A WASHOUT AND POLY SWAP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272340 GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/13 MM KNEE POLYETHYLENE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 141425 07630030862670

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention