BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S3 RM

    MDR report key: 16885914 · Received May 8, 2023

    Report

    Report Number
    3005180920-2023-00334
    Event Type
    Injury
    Date Received
    May 8, 2023
    Date of Event
    April 12, 2023
    Report Date
    May 8, 2023
    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 19 APRIL 2023: LOT 2105455: (B)(6) ITEMS MANUFACTURED AND RELEASED ON 18-MAY-2021. EXPIRATION DATE: 2026-05-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL DEVICES INVOLVED: BATCH REVIEWS PERFORMED ON 19 APRIL 2023 MOTO PARTIAL KNEE 02.18.IF4.08.RM TIBIAL INSERT FIX S4 RM - 8MM (K162084) LOT 2103536: (B)(6) ITEMS MANUFACTURED AND RELEASED ON 05-MAY-2021. EXPIRATION DATE: 2026-04-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(6) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. MOTO PARTIAL KNEE 02.18.TF4.RM TIBIAL TRAY FIX CEMENTED S4 RM (K162084) LOT 2103556: (B)(6) ITEMS MANUFACTURED AND RELEASED ON 27-MAY-2021. EXPIRATION DATE: 2026-05-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(6) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 1 YEAR 6 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE PATIENT FROM MOTO TO SPHERE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1955612 MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S3 RM KNEE CEMENTED FEMUR HSX MEDACTA INTERNATIONAL SA 02.18.003RM 2105455 07630030895586

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention