BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 6 LEFT

    MDR report key: 6112633 · Received November 18, 2016

    Report

    Report Number
    3005180920-2016-00599
    Event Type
    Injury
    Date Received
    November 18, 2016
    Date of Event
    October 21, 2016
    Report Date
    November 18, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2016 AND INCLUDES: THE REVISION WAS COMPLETED SUCCESSFULLY ON (B)(6) 2016. ALL IMPLANTS HAVE BEEN EXPLANTED. BATCH REVIEWS PERFORMED ON 14 NOVEMBER 2016. LOT 114267: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21 DECEMBER 2011. EXPIRATION DATE: 2016-11-30. 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. GMK-PRIMARY TIBIAL INSERT PS FIXED SIZE 6/10MM, CODE 02.07.0610PSF, LOT. 132864 (K090988) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25 SEPTEMBER 2013. EXPIRATION DATE: 2018-08-31. 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. GMK-PRIMARY FEMUR PS CEMENTED SIZE 7 LEFT, CODE 02.07.2207L, LOT. 130292 (K120790) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03 JUNE 2013. EXPIRATION DATE: 2018-04-30. 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. ON 17 NOVEMBER 2016 THE PATIENT MATCH DEPARTMENT PERFORMED A PATIENT MATCH REVIEW AND COMMENTED AS FOLLOWS: THE PROCESS ANALYSIS DID NOT REVEAL DEVIATIONS FROM THE STANDARD PROCEDURES.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN IN THE KNEE. A REVISION SURGERY WAS PLANNED DUE TO ARTHROFIBROSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763232 GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 6 LEFT TIBIAL TRAY FIXED CEMENTED JWH MEDACTA INTERNATIONAL SA 114267

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention