BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTO PARTIAL KNEE SYSTEM

    MDR report key: 23510665 · Received November 10, 2025

    Report

    Report Number
    3005180920-2025-01095
    Event Type
    Injury
    Date Received
    November 10, 2025
    Date of Event
    October 16, 2025
    Report Date
    November 10, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    HSX
    UDI-DI
    07630345705228
    PMA / PMN Number
    K213071
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 05 NOVEMBER 2025 MOTO PARTIAL KNEE 02.18.702RM MOTO MEDIAL SENSITIN FEMORAL COMPONENT S2 RM (K213071) LOT 2316362: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-OCT-2023. EXPIRATION DATE: 20-SEP-2028. 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.TF3.RM MOTO MEDIAL TIBIAL TRAY CEMENTED S3 RM (K162084) LOT 2429906: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-APR-2025. EXPIRATION DATE: 20-MAR-2030. 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. CLINICAL EVALUATION A REVISION SURGERY WAS PERFORMED APPROXIMATELY TWO WEEKS AFTER THE PRIMARY IMPLANTATION OF A UKA DUE TO TIBIAL BASEPLATE LOOSENING. THE AVAILABLE X-RAY IMAGES CLEARLY DEMONSTRATE MOBILIZATION OF THE TIBIAL COMPONENT, CHARACTERIZED BY ANTERIOR TILT AND SUBSIDENCE. ADDITIONALLY, THE FEMORAL COMPONENT APPEARS TO BE POSITIONED IN FLEXION, WITH AN IMPERFECT FIT TO THE FEMORAL BONE. THE EARLY FAILURE OF THE TIBIAL COMPONENT IS LIKELY MULTIFACTORIAL, POTENTIALLY RELATED TO IMPLANT POSITIONING AND BONE QUALITY. IN ADDITION, THE REPORTED OVERLOAD MAY HAVE CONTRIBUTED TO THE FAILURE.THERE IS NO EVIDENCE TO SUGGEST A DEVICE DEFECT. ROOT CAUSE: 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

    AT ABOUT 2 WEEKS AFTER THE PRIMARY, THE PATIENTCAME IN REPORTING PAIN DUE TO A LOOSE AND SUBSIDED BASEPLATE AND THE CAUSE IS UNKNOWN. THE PATIENT DIDN & RSQUO; T COMPLAIN ANY FALLS BUT MENTIONED POSSIBLY OVERDOING ACTIVITY, FEELING WELL FOR THE FIRST TIME IN YEARS. THE SURGEON FOUND THE BASEPLATE/POLYETHYLENE GROSSLY LOOSE AND SUSPECTED A CEMENT ISSUE, AS THE INITIAL FIT HAD BEEN EXCELLENT. THE SURGEON REVISED ALL COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY. ADDITIONAL NOTE FOR CLINICAL INTERNAL ANALYSES: THE X-RAY SHOWS THAT THE FEMORAL COMPONENT APPEARS TO BE POSITIONED IN FLEXION, WITH AN IMPERFECT FIT TO THE FEMORAL BONE; THEREFORETHE LEVEL 2 CHANGE THE CLASSIFICATION FROM ASSOCIATED COMPONENT TO MALPOSITIONING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2616117 MOTO PARTIAL KNEE SYSTEM MOTO MEDIAL SENSITIN FEMORAL COMPONENT S2 RM HSX MEDACTA INTERNATIONAL SA 02.18.702RM 2316362 07630345705228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention