BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK SPHERE FLEX TIBIAL INSERT SIZE 5 RIGHT

    MDR report key: 4840219 · Received June 10, 2015

    Report

    Report Number
    3006639916-2015-00112
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    April 9, 2015
    Report Date
    June 10, 2015
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    SF
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    LOCKING PIN OF INSERT BACKED OUT INTO POLY CAUSING METAL DEBRIS, POLY WEAR AND PAIN LEADING TO REVISION SURGERY. MEDACTA WAS NOTIFIED ON (B)(6) 2015 ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374588 GMK SPHERE FLEX TIBIAL INSERT SIZE 5 RIGHT FIXED TIBIAL INSERT 10 MM JWH MEDACTA INTERNATIONAL SA 133634

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention