BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MISHA KNEE SYSTEM

    MDR report key: 23596128 · Received November 19, 2025

    Report

    Report Number
    3008274656-2025-00009
    Event Type
    Injury
    Date Received
    November 19, 2025
    Date of Event
    November 18, 2024
    Report Date
    November 19, 2025
    Manufacturer
    MOXIMED, INC.
    Product Code
    QVV
    UDI-DI
    00856047005795
    PMA / PMN Number
    DEN220033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MISHA REMOVAL WAS COMPLETED WITHOUT COMPLICATION. ANALYSIS OF THE RETURNED DEVICE FOUND IT TO BE INTACT AND WELL-FUNCTIONING. A REVIEW OF MANUFACTURING RECORDS INDICATES THAT THE PRODUCT CONFORMED TO DESIGN AND MANUFACTURING SPECIFICATIONS. AT THE TIME OF MISHA IMPLANTATION, ADDITIONAL PROCEDURES OF ARTHROSCOPIC MEDIAL MENISCECTOMY AND CHONDROPLASTY OF THE PATELLA AND LATERAL TIBIAL PLATEAU WERE PERFORMED AND SOME LOSS OF MOTION PRIOR TO THE MISHA PROCEDURE WAS NOTED. THE CAUSE OF THE EVENT REMAINS UNKNOWN. THIS MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION EFFORT BASED ON ENHANCEMENTS MADE TO THE COMPANY'S COMPLAINT HANDLING PROCESSES. THIS EVENT IS BEING FILED IN ACCORDANCE WITH A CAPA WHICH HAS BEEN OPENED TO MANAGE THE ACTIONS AND ANY REQUIRED MDR REPORTING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT UNDERWENT MISHA IMPLANTATION FOR OA ALONG WITH ARTHROSCOPIC MEDIAL MENISCECTOMY AND CHONDROPLASTY OF THE PATELLA AND LATERAL TIBIAL PLATEAU WITH SOME LOSS OF MOTION PRIOR TO THE MISHA PROCEDURE. MORE THAN 6 MONTHS LATER, THE PATIENT EXPERIENCED LOSS OF MOTION AND UNDERWENT ARTHROSCOPIC DEBRIDEMENT, ANTERIOR AND POSTERIOR CAPSULE RELEASE REGAINING RANGE OF MOTION. THE PATIENT EXPERIENCED LOSS OF MOTION AGAIN AND UNDERWENT MISHA REMOVAL AND FULL RANGE OF MOTION WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2748436 MISHA KNEE SYSTEM MEDIAL KNEE IMPLANTED SHOCK ABSORBER, PRODUCT CODE: QVV QVV MOXIMED, INC. 23092102 00856047005795

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention