BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 2 R

    MDR report key: 14692612 · Received June 15, 2022

    Report

    Report Number
    3005180920-2022-00449
    Event Type
    Injury
    Date Received
    June 15, 2022
    Date of Event
    May 16, 2022
    Report Date
    June 15, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819872
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 10-JUN-2022. LOT 132743: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-AUG-2013. EXPIRATION DATE: 2018-06-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL COMPONENTS INVOLVED: GMK-PRIMARY 02.07.2213R FEMUR CEMENTED PS SIZE 3NARROW / RIGHT (K122232) LOT. 134788: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-OCT-2013. EXPIRATION DATE: 2018-09-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-PRIMARY 02.07.0210PSF TIBIAL INSERT PS FIXED SIZE 2/10MM (K090988) LOT. 136088: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-MAR-2014. EXPIRATION DATE: 2019-02-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: AT 8 YEARS AFTER PRIMARY TKA THE PATELLA DEVELOPS PROBLEMS AND A NI ALLERGY IS DEVELOPED TOO. SUBSTITUTION IS REQUIRED TO OFFER LOWER ION RELEASE AND TREAT THE PATELLA ISSUE BY SECONDARY RESURFACING OF THE ROTULA. NO DEVICE DEFICIENCY CAUSED THIS ADVERSE EVENT. PRELIMINARY INVESTIGATION PERFORMED BY R&D KNEE PROJECT MANAGER: REVISION SURGERY OF A GMK PRIMARY PS KNEE DUE TO PATELLA ISSUE AFTER MORE THAN 7 YEARS FROM PRIMARY IMPLANTATION. THE INSERT LOOKS DIRTY AND STILL COVERED BY THE BLOOD. IT IS NOT POSSIBLE TO NOTICE ANY UNEXPECTED DAMAGE OR WORN-OUT SURFACES. NO ELEMENTS RELEVANT TO THE EVENT CAN BE NOTED IN THE ANALYSIS OF THE PICTURE OF THE EXPLANTED COMPONENT.

    Description of Event or Problem · 0

    REVISION SURGERY AND PATELLA RESURFACING WERE PERFORMED AFTER ABOUT 8 YEARS FROM THE PRIMARY DUE TO PATELLA PAIN AND NICKEL ALLERGY. GMK-HINGE SENSITIN WITH PATELLA E-CROSS HAVE BEEN IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1847563 GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 2 R KNEE TIBIAL TRAY FIXED CEMENTED JWH MEDACTA INTERNATIONAL SA 02.07.1202R 132743 07630030819872

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention