BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTO PARTIAL KNEE SYSTEM

    MDR report key: 25253485 · Received May 22, 2026

    Report

    Report Number
    3005180920-2026-00506
    Event Type
    Injury
    Date Received
    May 22, 2026
    Date of Event
    May 6, 2026
    Report Date
    May 22, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSX
    UDI-DI
    07630345712103
    PMA / PMN Number
    K213071
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 22 MAY 2026: MOTO PARTIAL KNEE 02.18.EIF6.08.LM MOTO MEDIAL E-CROSS TIBIAL INSERT S6 LM - H8 (K213071) LOT. 2314140: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-OCT-2023. EXPIRATION DATE: 2028-SEP-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. MOTO PARTIAL KNEE 02.18.006LM MOTO MEDIAL FEMORAL COMPONENT S6 LM (K162084) LOT. 2514319: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-JUL-2025. EXPIRATION DATE: 2030-JUL-09. 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.TF6.LM MOTO MEDIAL TIBIAL TRAY S6 LM LOT. 172241B: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-SEP-2017. EXPIRATION DATE: 2022-AUG-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS FROM THE SAME LOT HAVE BEEN SOLD, WITH NO SIMILAR EVENT REPORTED DURING THE REVIEW PERIOD. FIVE ITEMS HAVE BEEN RESTERILIZED; OF THESE, THREE HAVE BEEN SOLD TO DATE. ROOT CAUSE: INFECTION IS A KNOWN POSSIBLE COMPLICATION OF ANY SURGERY. ALTHOUGH NO ROOT CAUSE CAN BE ESTABLISHED, THERE IS NO INDICATION THAT ANY ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DOCUMENT REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED CAUSE.

    Description of Event or Problem · 0

    REVISION SURGERY DUE TO INFECTION AFTER ABOUT 1 MONTH FROM PRIMARY. THE PATIENT HAD PRIMARY LEFT KNEE SURGERY ON (B)(6) 2026. ON (B)(6) 2026, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE MOTO S6 LM - H8 INSERT TO A SAME SIZE INSERT (MDR 2026-00482). PRESENTLY, ON (B)(6) 2026, THE PATIENT CAME IN DUE TO CONTINUED SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED THE MOTO FEMORAL COMPONENT AND MOTO TIBIAL TRAY FROM THE PRIMARY SURGERY AND REMOVED THE MOTO INSERT FROM THE FIRST REVISION AND IMPLANTED ANTIBIOTIC SPACERS TO TREAT THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368103 MOTO PARTIAL KNEE SYSTEM MOTO MEDIAL E-CROSS TIBIAL INSERT S6 LM - H8 HSX MEDACTA INTERNATIONAL SA 02.18.EIF6.08.LM 2314140 07630345712103

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention