BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-REVISION FEMUR REVISION PS SIZE 3 L

    MDR report key: 14202531 · Received April 26, 2022

    Report

    Report Number
    3005180920-2022-00308
    Event Type
    Injury
    Date Received
    April 26, 2022
    Date of Event
    March 30, 2022
    Report Date
    April 26, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030821400
    PMA / PMN Number
    K102437
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 11 APRIL 2022: LOT 164821: 27 ITEMS MANUFACTURED AND RELEASED ON 26-SEPT-2016. EXPIRATION DATE: 2021-09-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 25 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: GMK-REVISION 02.07.0312SCF FIXED TIBIAL INSERT SC SIZE 3/12MM (K103170) LOT. 167085. BATCH REVIEW PERFORMED ON 11 APRIL 2022: LOT 167085: 18 ITEMS MANUFACTURED AND RELEASED ON 02-FEB-2017. EXPIRATION DATE: 2022-01-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 13 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL IMPLANT INVOLVED: GMK-REVISION 02.07.FCL12105 EXTENSION STEM - FLUTED Ø 12 L 105 (K120790) LOT. 181245. BATCH REVIEW PERFORMED ON 11 APRIL 2022: LOT 181245: 15 ITEMS MANUFACTURED AND RELEASED ON 17-MAY-2018. EXPIRATION DATE: 2023-05-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 11 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING PAIN AND STIFFNESS IN THE KNEE AND THE CAUSE OF THE PAIN AND STIFFNESS IS UNKNOWN. AT ALMOST 2 YEARS AND 10 MONTHS AFTER PRIMARY THE SURGEON REVISED THE EXTENSION STEM, FEMUR, AND POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1134115 GMK-REVISION FEMUR REVISION PS SIZE 3 L CEMENTED FEMORAL COMPONENT JWH MEDACTA INTERNATIONAL SA 02.07.2403L 164821 07630030821400

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention