BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GMK EFFICIENCY TRIAL KEEL S5-6

    MDR report key: 7446946 · Received April 20, 2018

    Report

    Report Number
    3005180920-2018-00256
    Event Type
    Malfunction
    Date Received
    April 20, 2018
    Date of Event
    March 22, 2018
    Report Date
    April 20, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    UDI-DI
    07630030878640
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 20 APRIL 2018. LOT 171250: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06 MARCH 2017. EXPIRATION DATE: 2022-02-21. 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 SEMIFINISHED LOT MAT16658: 2400 ITEMS MANUFACTURED AND RELEASED ON 18 NOVEMBER 2015. NO ANOMALIES FOUND RELATED TO THE ISSUE. VISUAL INSPECTION PERFORMED ON 20 APRIL 2018 BY (B)(4) PRODUCT MANAGER: THE BREAKING OF THE TRIAL KEEL COULD BE DUE TO DIFFERENT FACTORS SUCH AS SCLEROTIC BONE, NOT ENOUGH PREPARATION OF THE KEEL WINGS SIDE WITH THE RISK OF EXCESSIVE IMPACTING FORCE FOR TRIAL KEEL PLACEMENT. DURING THE VISUAL INSPECTION HAVE ALSO BEEN ANALYZED THE PICTURE OF THE COMPLAINT.

    Description of Event or Problem · 1

    TRIAL KEEL BREAKAGE DURING SURGERY (WING BROKEN). THE PATIENT HAD SEVERE SCLEROTIC BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291876 GMK EFFICIENCY TRIAL KEEL S5-6 SURGICAL INSTRUMENT FOR KNEE LXH MEDACTA INTERNATIONAL SA 171250 07630030878640

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other