BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 4 RIGHT

    MDR report key: 7013795 · Received November 9, 2017

    Report

    Report Number
    3005180920-2017-00643
    Event Type
    Injury
    Date Received
    November 9, 2017
    Date of Event
    October 10, 2017
    Report Date
    November 9, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819919
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEWS PERFORMED ON 09 NOVEMBER 2017. LOT 147892: 82 ITEMS MANUFACTURED AND RELEASED ON 26 FEBRUARY 2015. EXPIRATION DATE: 2020-01-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 4/10 MM, CODE 02.07.0410PSF, LOT. 147969 (K090988) (B)(4). GMK-PRIMARY FEMUR CEMENTED PS SIZE 4 NARROW / RIGHT, CODE 02.07.2214R, LOT. 147881 (K122232) (B)(4).

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN IN THE RIGHT KNEE. THE SURGEON REVIEW THE PATIENT AND DETERMINED A REVISION WAS REQUIRED. THE SURGEON STATED THAT IT IS WAS INFECTION (NOT BACTERIAL). INCISION AND DRAINAGE WAS PERFORMED THEN CEMENTED ANTIBIOTICS SPACERS WERE LEFT IN THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794745 GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 4 RIGHT TIBIAL TRAY FIXED CEMENTED JWH MEDACTA INTERNATIONAL SA 147892 07630030819919

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention