BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/10MM

    MDR report key: 8137080 · Received December 6, 2018

    Report

    Report Number
    3005180920-2018-00975
    Event Type
    Injury
    Date Received
    December 6, 2018
    Date of Event
    November 8, 2018
    Report Date
    December 6, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030816499
    PMA / PMN Number
    K103170
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON (B)(6) 2018; LOT 140467: 30 ITEMS MANUFACTURED AND RELEASED ON 06 MAR 2014; EXPIRATION DATE: 2019-01-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 24 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: BATCH REVIEW PERFORMED ON (B)(6) 2018: GMK-REVISION 02.07.0682R; REVISION FIXED TIBIAL TRAY CEMENTED SIZE 2 R (K123721) LOT 184299: 11 ITEMS MANUFACTURED AND RELEASED ON 11-JUL-2018; EXPIRATION DATE: 2023-07-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 3 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO AN UNSTABLE COMPETITOR'S KNEE CONSTRUCT. THE SURGEON REVISED ALL COMPETITOR HARDWARE WITH MEDACTA HARDWARE. THE SURGEON ATTEMPTED TO IMPLANT THE S2 10MM SEMI CONSTRAINED (LOT 140467) INSERT BUT IT WOULD NOT FIT INTO THE TIBIAL TRAY. THE SURGEON THEN SUBLUXED THE TIBIA FORWARD IN AN EFFORT TO INSERT A SECOND S2 10MM SEMI CONSTRAINED INSERT. WHEN THE SURGEON SUBLUXED THE TIBIA FORWARD, THE LCL TENDON TORE AWAY BONE FROM THE FEMUR. THE LCL TENDON WAS THEN SCREWED INTO PLACE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    976785 GMK-REVISION FIXED TIBIAL INSERT SC SIZE 2/10MM KNEE TIBIAL INSERT JWH MEDACTA INTERNATIONAL SA 140467 07630030816499

    Patients

    Seq Age Sex Outcome Treatment
    1 Other