BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S4 RM

    MDR report key: 17497350 · Received August 10, 2023

    Report

    Report Number
    3005180920-2023-00649
    Event Type
    Injury
    Date Received
    August 10, 2023
    Date of Event
    July 27, 2023
    Report Date
    August 10, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSX
    UDI-DI
    07630030895609
    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 3 AUGUST 2023. LOT 2103522: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-APR-2021. EXPIRATION DATE: 2026-MAR-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL 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 3 AUGUST 2023: MOTO PARTIAL KNEE 02.18.IF4.09.RM TIBIAL INSERT FIX S4 RM - 9MM (K162084) LOT 2103537: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-MAY-2021. EXPIRATION DATE: 2026-APR-22. 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. MOTO PARTIAL KNEE 02.18.TF4.RM TIBIAL TRAY FIX CEMENTED S4 RM (K162084) LOT 2105880: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-AUG-2021. EXPIRATION DATE: 2026-JUL-20. 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.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING DISCOMFORT AND PAIN AND THE REASON IS UNKNOWN. ABOUT 1 YEAR AND 6 MONTHS, THE SURGEON REVISED THE PATIENT FROM A MOTO KNEE TO A TOTAL KNEE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1090102 MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S4 RM KNEE FEMORAL COMPONENT HSX MEDACTA INTERNATIONAL SA 2103522 07630030895609

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention