BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK HINGE TIBIAL INSERT

    MDR report key: 4805667 · Received May 27, 2015

    Report

    Report Number
    3005180920-2015-00104
    Event Type
    Injury
    Date Received
    May 27, 2015
    Report Date
    September 4, 2015
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    KRO
    PMA / PMN Number
    K130299
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 02 SEPTEMBER 2015 A FINAL REPORT WAS PREPARED WITH THE INFORMATION ALREADY REPORTED INTO THE INITIAL REPORT. ON 02 SEPTEMBER 2015, THE FINAL REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON (B)(4) 2015: LOT 120017: (B)(4) INSERTS MANUFACTURED AND RELEASED ON(B)(4) 2012. EXPIRATION DATE 2017-03-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO OTHER INSERTS OF THE SAME LOT HAVE BEEN SOLD. ON (B)(6) 2015 THE MED AFFAIRS DIR MADE THE FOLLOWING COMMENT, WITH THE ANALYSIS OF THE X-RAY: PERFECT IMPLANTATION IN A DIFFICULT CASE. THE SCREW HAS BEEN DESIGNED TO RETAIN THE INSERTS THAT MAY HAVE STRESS CONDITIONS THREATENING TO LOOSE THEM. UNFORTUNATELY, IT MAY ALSO HAPPEN THAT THE SCREW GETS LOOSE IN TURN. IN THIS CASE, SCREW TIGHTENING AND INSERT SUBSTITUTION WAS ACHIEVED WITH A MINOR OPERATION. CONSIDERATIONS ARE BEING MADE IN ORDER TO EVALUATE THE RISK/BENEFIT RATIO OF A POSSIBLE SUPPRESSION OF THE INSERT RETAINING SCREW, EVALUATING SAFETY IN EITHER SITUATIONS. ON (B)(6) 2015 IT WAS CONFIRMED THAT THE INSERT WILL NOT BE AVAILABLE FOR ANALYSIS.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343196 GMK HINGE TIBIAL INSERT KRO MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1