BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION FIXED TIBIAL TRAY CEMENTED SIZE 6 L

    MDR report key: 8615711 · Received May 16, 2019

    Report

    Report Number
    3005180920-2019-00381
    Event Type
    Injury
    Date Received
    May 16, 2019
    Date of Event
    April 16, 2019
    Report Date
    May 16, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819940
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 14 MAY 2019: LOT 134272: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-NOV-2013. EXPIRATION DATE: 2018-09-30. 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. ADDITIONAL IMPLANTS INVOLVED: GMK-REVISION 02.07.2406L FEMUR REVISION PS SIZE 6 L (K102437), LOT 157217: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-FEB-2016. EXPIRATION DATE: 2021-01-23. 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-REVISION 02.07.0612SCF FIXED TIBIAL INSERT SC SIZE 6/12MM (K103170), LOT 124952: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-MAR-2013. EXPIRATION DATE: 2018-01-31. 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.

    Description of Event or Problem · 1

    THE PATIENT HAD A PRIMARY KNEE SURGERY ON (B)(6) 2017 AND SHE WAS ALREADY REVISED ON (B)(6) 2017 DUE TO PAIN CAUSED FROM FALLING: THE SURGEON REVISED THE FEMORAL COMPONENT AND POLY (MDR 2017-00827). ABOUT 1 YEAR AND 4 MONTHS AFTER THAT FIRST REVISION, THE PATIENT HAD ANOTHER REVISION SURGERY DUE TO RUPTURED PATELLA TENDON. FEMORAL AND TIBIAL COMPONENTS SWAPPED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411571 GMK-REVISION FIXED TIBIAL TRAY CEMENTED SIZE 6 L KNEE TIBIAL TRAY CEMENTED JWH MEDACTA INTERNATIONAL SA 134272 07630030819940

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention