BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 3 L

    MDR report key: 7147254 · Received December 27, 2017

    Report

    Report Number
    3005180920-2017-00780
    Event Type
    Injury
    Date Received
    December 27, 2017
    Date of Event
    November 27, 2017
    Report Date
    December 27, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819889
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 27 DECEMBER 2017 LOT 153505: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21 SEPT 2015. EXPIRATION DATE: 2020-07-31 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 STD CEMENTED SIZE 2 L REFERENCE 02.07.2002L (K090988) LOT. 133375: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10 SEPT 2013. EXPIRATION DATE: 2018-08-30. 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. INVESTIGATION PERFORMED ON 20 DECEMBER 2017 BY PATIENT MATCH DEPARTMENT: OUR ANALYSIS OF THE MYKNEE PROCESS OF THIS CASE FOUND NO DEVIATIONS FROM THE STANDARD PROCEDURES. EACH STEP HAS BEEN PERFORMED CORRECTLY. THE NON-USE OF THE WEDGE ON THE MEDIAL COMPARTMENT OF THE TIBIA MAY HAVE CONTRIBUTED TO THE INSTABILITY OF THE KNEE.

    Description of Event or Problem · 1

    REVISION SURGERY DUE TO FEMUR AND TIBIAL LOOSENING AFTER 1 YEAR AND 5 MONTHS AFTER PRIMARY. THE PATIENT HAD A PRIMARY SURGERY ON (B)(6) 2016. ON (B)(6) 2017 THE SURGEON REVISED THE TIBIAL TRAY, INSERT AND FEMUR DUE TO IMPLANTS LOOSENING. THE CEMENT DID NOT ADHERE TO THE IMPLANT BUT THEY DIDN'T COME OUT RIGHT AWAY. HE BEAT ON THEM WITH A BONE TAMP; THE FEMUR CAME OFF EASIER THAN THE TIBIA, HE USED OSTEOTOMES FOR THE TIBIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    926718 GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 3 L TIBIAL TRAY FIXED CEMENTED JWH MEDACTA INTERNATIONAL SA 153505 07630030819889

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention