BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK-PRIMARY 02.07.0410PSF TIBIAL INSERT PS FIXED SIZE 4/10MM LOT. 2241247

    MDR report key: 18111209 · Received November 10, 2023

    Report

    Report Number
    3005180920-2023-00885
    Event Type
    Injury
    Date Received
    November 10, 2023
    Date of Event
    October 13, 2023
    Report Date
    November 10, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030817649
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 25 OCTOBER 2023: LOT 2241247: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-JAN-2023. EXPIRATION DATE: 2027-12-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 22 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: FEW WEEKS AFTER PRIMARY CEMENTED TKA THE WHOLE SYSTEM NEEDS TO BE REVISED. FROM THE IMAGES SUPPLIED, THE POSITION OF THE FEMORAL COMPONENT IS SUBOPTIMAL, WITH PARTICULAR REFERENCE TO THE PATELLAR BONE. THE TIBIAL TRAY IS ALIGNED ACCORDING TO A CRITERION THAT IS NOT SPECIFIED IN THE REPORT AND THAT WE WERE UNABLE TO IDENTIFY. IT ALSO APPEARS SLIGHTLY UNDERSIZED. WE THINK THAT THE ROOT CAUSE FOR THIS REVISION IS SUBOPTIMAL POSITION OF THE PRIMARY COMPONENTS. OTHER DEVICES INVOLVED: GMK-PRIMARY 02.07.12.1204L TIBIAL TRAY FIXED CEMENTED SIZE 4 L (K090988) LOT 2212410: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-SEP-2022. EXPIRATION DATE: 2027-09-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 22 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. GMK-PRIMARY 02.07.2205L FEMUR PS CEMENTED SIZE 5 L (K090988) LOT 1902638: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-MAY-2019. EXPIRATION DATE: 2024-05-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 22 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    REVISION SURGERY FOR KNEE STIFFNESS AT ABOUT 4 MONTHS FROM PRIMARY. ALL DEVICES WERE REVISED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103056 GMK-PRIMARY 02.07.0410PSF TIBIAL INSERT PS FIXED SIZE 4/10MM LOT. 2241247 KNEE TIBIAL INSERT PS FIXED JWH MEDACTA INTERNATIONAL SA 2241247 07630030817649

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention