BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY FEMUR PS CEMENTED SIZE 6 R

    MDR report key: 9961874 · Received April 15, 2020

    Report

    Report Number
    3005180920-2020-00241
    Event Type
    Injury
    Date Received
    April 15, 2020
    Date of Event
    March 19, 2020
    Report Date
    April 15, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030820892
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 22-MAR-2020: LOT 134200: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-OCT-2013. EXPIRATION DATE: 30.09.2018. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. CLINICAL EVALUATION: TOTAL KNEE REVISION SURGERY PERFORMED 4 YEARS AND 4 MONTHS AFTER CEMENTED TKA IN A 62 YEAR OLD ACTIVE MAN. BONE ALTERATIONS INVOLVING FEMUR, TIBIA AND PATELLA ARE VISIBLE IN THE RADIOGRAPHIC IMAGES PROVIDED, BUT WE HAVE NO CLUES AS TO THEIR POSSIBLE ORIGIN. ASEPTIC LOOSENING IS A POSSIBLE LITERATURE DESCRIBED ADVERSE EVENT AFTER TKA AND CAUSES ARE OFTEN UNKNOWN. HIGH LEVEL OF ACTIVITY MAY BE A RISK FACTOR FOR ASEPTIC LOOSENING BUT ALSO OTHER UNKNOWN CONDITIONS MAY HAVE CONTRIBUTED TO THIS FAILURE. THE METAPHYSEAL BONE ALTERATIONS ARE UNUSUALLY SIGNIFICANT AND MUST HAVE CONTRIBUTED IN A DETERMINANT MEASURE TO THE LOOSENING. THE REASON OF THIS EVENT CANNOT BE DETERMINED. OTHER DEVICE INVOLVED IN THE EVENT: GMK-PRIMARY 02.07.1205R TIBIAL TRAY FIXED CEMENTED SIZE 5 R LOT. 153498 (K090988). BATCH REVIEW PERFORMED ON 22-MAR-2020: LOT 153498: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-AUG-2015. EXPIRATION DATE: 30.06.2020. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED DUE TO LOOSENING OF THE ENTIRE PROSTHESIS, PATELLA AS WELL, AFTER ABOUT 5 YEARS FROM THE PRIMARY SURGERY. ALL COMPONENTS HAVE BEEN REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425537 GMK-PRIMARY FEMUR PS CEMENTED SIZE 6 R FEMUR PS CEMENTED JWH MEDACTA INTERNATIONAL SA 02.07.2206R 134200 07630030820892

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention