BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S3 RM

    MDR report key: 19565506 · Received June 19, 2024

    Report

    Report Number
    3005180920-2024-00418
    Event Type
    Injury
    Date Received
    June 19, 2024
    Date of Event
    May 16, 2024
    Report Date
    June 19, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSX
    UDI-DI
    07630030895586
    PMA / PMN Number
    K162084
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 24 MAY 2024 LOT 2001410: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-JUN-2020. EXPIRATION DATE: 2025-06-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL IMPLANTS INVOLVED. BATCH REVIEW PERFORMED ON 24 MAY 2024 ON MOTO PARTIAL KNEE 02.18.IF4.10.RM TIBIAL INSERT FIX S4 RM - 10MM (K162084) LOT. 172314. LOT 172314: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-OCT-2017. EXPIRATION DATE: 2022-10-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 24 MAY 2024 ON MOTO PARTIAL KNEE 02.18.TF4.RM TIBIAL TRAY FIX CEMENTED S4 RM (K162084) LOT. 2003450 LOT 2003450: 20 ITEMS MANUFACTURED AND RELEASED ON 22-JULY-2020. EXPIRATION DATE: 2025-07-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 20 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    REVISION SURGERY 2 YEARS AND 1 MONTH POST PRIMARY FOR PAIN IN THE LATERAL COMPARTMENT AND THE CAUSE IS UNKNOWN. THE SURGEON CONVERTED THE PATIENT FROM A UNI TO A SPHERE KNEE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596084 MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S3 RM KBEE PARTIAL KNEE SZSTEM CEMENTED FEMORAL COMPONENT HSX MEDACTA INTERNATIONAL SA 2001410 07630030895586

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention