BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 3/14MM

    MDR report key: 5903224 · Received August 25, 2016

    Report

    Report Number
    3005180920-2016-00431
    Event Type
    Injury
    Date Received
    August 25, 2016
    Date of Event
    July 26, 2016
    Report Date
    August 25, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEFT KNEE HAD BEEN ALREADY REVISED ON (B)(6) 2014 (MDR 2014-00197): THE 14MM POLY WAS REVISED WITH A 20MM POLY. BATCH REVIEWS PERFORMED ON 05 AUGUST 2016: LOT 102827: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22 OCTOBER 2010; EXPIRATION DATE: 2015-09-30. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 3/20MM, CODE 02.07.0320PSF, LOT. 132861 (K090988) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25 SEPTEMBER 2013; EXPIRATION DATE: 2018-08-31. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF INSTABILITY. THE RIGHT KNEE HAD A 14MM POLY THAT WAS REVISED WITH A 20MM. THE LEFT KNEE HAD A 20MM POLY WHICH WAS REVISED WITH ANOTHER 20MM POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555711 GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 3/14MM TIBIAL INSERT FIXED JWH MEDACTA INTERNATIONAL SA 102827

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention