BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY FEMUR STD CEMENTED SIZE 3

    MDR report key: 15996267 · Received December 16, 2022

    Report

    Report Number
    3005180920-2022-00926
    Event Type
    Injury
    Date Received
    December 16, 2022
    Date of Event
    November 21, 2022
    Report Date
    December 16, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030820205
    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 22 NOVEMBER 2022. LOT 122092: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 2-AUG-2012. EXPIRATION DATE: 2017-JUN-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT: 10 YEARS AFTER PRIMARY TKA THE METAL COMPONENTS, AND PRESUMABLY MOSTLY THE TIBIA, GET LOOSE AND NEED REPLACEMENT. ASEPTIC LOOSENING IS A POSSIBLE ADVERSE EVENT FOLLOWING TKA, DESCRIBED IN LITERATURE. ITS INCIDENCE INCREASES WITH TIME. THERE IS NO REASON TO SUSPECT A FAULTY DEVICE AT THE ORIGIN OF THIS PROBLEM. ADDITIONAL IMPLANT INVOLVED: BATCH REVIEW PERFORMED ON 22 NOVEMBER 2022 ON GMK-PRIMARY 02.07.1203R TIBIAL TRAY FIXED CEMENTED SIZE 3 R (K090988) LOT. 121650. LOT 121650: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 7-SEP-2012. EXPIRATION DATE: 2017-JUN-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    ABOUT 10 YEARS AFTER THE PRIMARY SURGERY, ALL COMPONENTS HAVE BEEN REVISED DUE TO TIBIAL AND FEMORAL COMPONENTS MOBILIZATION. THE PATIENT PREVIOUSLY UNDERWENT REVISION SURGERY WHERE THE INSERT WAS REVISED AND THE PATELLA BONE WAS RESURFACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2513683 GMK-PRIMARY FEMUR STD CEMENTED SIZE 3 KNEE CEMENTED FEMUR JWH MEDACTA INTERNATIONAL SA 02.07.2003R 122092 07630030820205

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention