BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTO PARTIAL KNEE SYSTEM - MEDIAL

    MDR report key: 23220339 · Received October 6, 2025

    Report

    Report Number
    3005180920-2025-00971
    Event Type
    Injury
    Date Received
    October 6, 2025
    Date of Event
    September 10, 2025
    Report Date
    November 6, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSX
    PMA / PMN Number
    K162084
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTIONS: B5: EVENT DESCRIPTION ON (B)(6) 2024, THE PATIENT UNDERWENT A PRIMARY SURGERY WITH A MOTO PARTIAL KNEE IMPLANT. ON (B)(6) 2025, A REVISION SURGERY WAS PERFORMED. THE IMPLANT SEATING WAS CORRECT, WITH NO SIGNS OF TIBIAL LOOSENING. THE REVISION WAS CONDUCTED DUE TO AN ALLERGIC REACTION. ALL COMPONENTS WERE REVISED TO THE SPHERIKA SENSITIN SYSTEM, AND THE SURGERY WAS SUCCESSFULLY COMPLETED. D6A: IF IMPLANTED, GIVE DATE (DD-MMMYYYY): (B)(6) 2024 ANNEX A: 1524 - DEVICE APPEARS TO TRIGGER REJECTION ANNEX D: 1907 - ALLERGIC REACTION. ADDITIONAL INFO: 6B. IF EXPLANTED, GIVE DATE (DD-MMMYYYY): (B)(6) 2025. ANNEX D: 22- KNOWN INHERENT DEVICE RISK -BATCH REVIEWS PERFORMED ON 22 SEPTEMBER 2025 MOTO PARTIAL KNEE 02.18.002LM MOTO MEDIAL FEMORAL COMPONENT S2 LM (K162084) LOT. 2403525: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25 MARCH 2024. EXPIRATION DATE: 11 MARCH 2029. 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.IF3.08.LM MOTO MEDIAL TIBIAL INSERT S3 LM - H8 8 (K162084)LOT. 2212257: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30 SEPT 2022 EXPIRATION DATE: 13 SEPT 2027. 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. THE REPORTED CAUSE WAS METAL ALLERGY WITH NO ALLEGED DEVICE DEFICIENCY OR CONTRIBUTING FACTOR, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 22 SEPTEMBER 2025. LOT 2305250: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-JULY-2023. EXPIRATION DATE: 17-JUNE-2028. 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. CONCLUSION: BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, WHILE THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    ON (B)(6) 2024, THE PATIENT UNDERWENT A PRIMARY SURGERY WITH A MOTO PARTIAL KNEE IMPLANT. ON (B)(6) 2025, A REVISION SURGERY WAS PERFORMED. THE IMPLANT SEATING WAS CORRECT, WITH NO SIGNS OF TIBIAL LOOSENING. THE REVISION WAS CONDUCTED DUE TO AN ALLERGIC REACTION. ALL COMPONENTS WERE REVISED TO THE SPHERIKA SENSITIN SYSTEM, AND THE SURGERY WAS SUCCESSFULLY COMPLETED.

    Description of Event or Problem · 0

    ON (B)(6) 2024, THE PATIENT UNDERWENT PRIMARY SURGERY WITH A MOTO PARTIAL KNEE IMPLANT. ON (B)(6) 2025, THE PATIENT IS SCHEDULED FOR REVISION SURGERY DUE TO TIBIAL LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2692766 MOTO PARTIAL KNEE SYSTEM - MEDIAL TIBIAL TRAY FIX CEMENTED S3 LM HSX MEDACTA INTERNATIONAL SA 02.18.TF3.LM 2305250

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Required Intervention