BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 3 L

    MDR report key: 13060403 · Received December 22, 2021

    Report

    Report Number
    3005180920-2021-01002
    Event Type
    Injury
    Date Received
    December 22, 2021
    Date of Event
    November 29, 2021
    Report Date
    January 21, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819889
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR AT 9 YEARS AFTER PRIMARY TKA BOTH COMPONENTS MOBILIZE QUITE SIGNIFICANTLY, WHILE THE PATELLA REMAINS WELL FIXED. NO TRAUMATIC EVENT IS REPORTED, AND NO INFECTION. THE REASONS FOR SUCH A SUDDEN AND MACROSCOPIC LOOSENING ARE NOT KNOWN AND CANNOT BE DETERMINED WITH THE INFORMATION AT HAND. IDIOPATHIC ASEPTIC LOOSENING IS A POSSIBLE ADVERSE EVENT FOLLOWING TKA, REPORTED IN LITERATURE. THERE IS NO REASON TO SUSPECT FAULTY DEVICES, WITH THE INFORMATION AT HAND.

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 09 DECEMBER 2021: LOT 122122: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-AUG-2012. EXPIRATION DATE: 2017-JUN-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 1-1-2017. ADDITIONAL COMPONENT INVOLVED: GMK-PRIMARY 02.07.2204L FEMUR PS CEMENTED SIZE 4 L (K090988) LOT. 112990. LOT 112990: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-OCT-2011. EXPIRATION DATE: 2016-AUG-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 1-1-2017.

    Description of Event or Problem · 0

    REVISION SURGERY AT 9 YEARS AND 1 MONTH AFTER PRIMARY DUE TO FEMUR AND TIBIAL IMPLANT MOBILIZATION. ALL IMPLANTS REVISED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1964145 GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 3 L KNEE TIBIAL BASEPLATE CEMENTED JWH MEDACTA INTERNATIONAL SA 02.07.1203L 122122 07630030819889

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention