BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S3 LM

    MDR report key: 14546964 · Received May 31, 2022

    Report

    Report Number
    3005180920-2022-00420
    Event Type
    Injury
    Date Received
    May 31, 2022
    Date of Event
    May 5, 2022
    Report Date
    May 31, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSX
    PMA / PMN Number
    K162084
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 12 MAY 2022: LOT 2101833: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-APR-2021. EXPIRATION DATE: 2026-03-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL COMPONENTS INVOLVED: MOTO PARTIAL KNEE 02.18.TF5.LM TIBIAL TRAY FIX CEMENTED S5 LM (K162084) LOT. 2012121: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-MARCH-2021. EXPIRATION DATE: 2026-02-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT. MOTO PARTIAL KNEE 02.18.IF5.09.LM TIBIAL INSERT FIX S5 LM - 9MM (K162084) LOT. 1910833: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-FEB-2020. EXPIRATION DATE: 2025-02-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    REVISION SURGERY AT ABOUT 8 MONTHS FROM PRIMARY FOR KNEE PAIN. DURING THE REVISION SURGERY THE IMPLANTS WERE ASSESSED, WELL FIXED , AND POSITIONED PERFECTLY. ALL COMPONENTS REVISED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1611477 MOTO PARTIAL KNEE ANATOMICAL FEMORAL COMPONENT CEMENTED S3 LM KNEE UNICOMPARTIMENTAL FEMORAL COMPONENT CEMENTED HSX MEDACTA INTERNATIONAL SA 2101833

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention