BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MISHA KNEE SYSTEM

    MDR report key: 19070568 · Received April 9, 2024

    Report

    Report Number
    3008274656-2024-00001
    Event Type
    Injury
    Date Received
    April 9, 2024
    Date of Event
    March 13, 2024
    Report Date
    June 7, 2024
    Manufacturer
    MOXIMED, INC.
    Product Code
    QVV
    UDI-DI
    00856047005795
    PMA / PMN Number
    DEN220033
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING PROVIDED DUE TO THE DEVICE REMOVAL WHICH TOOK PLACE AFTER THE INITIAL REPORT OF DEVICE MALFUNCTION WAS SUBMITTED. AN UPDATE ON THE INVESTIGATION IS ALSO BEING PROVIDED. A REVIEW OF MANUFACTURING RECORDS INDICATES THAT THE PRODUCT CONFORMED TO DESIGN AND MANUFACTURING SPECIFICATIONS. THE DEVICE WAS RETURNED, AND THE MALFUNCTION WAS CONFIRMED ON ANALYSIS. A SUDDEN GIVING WAY OF THE KNEE MAY LEAD TO INSTABILITY, POTENTIAL FALLS AND POSSIBLE DISTORTION OF THE KNEE INTO NON PHYSIOLOGICAL POSITIONS. THE KNEE WAS AND REMAINS STABLE. THE KNEE GIVING WAY EVENTS ARE LIKELY ASSOCIATED WITH THE PRESENCE OF KNEE OA OR WEAK QUADRICEPS. GIVEN THE TEMPORAL PROXIMITY OF THE KNEE GIVING WAY AND SUBSEQUENT SENSATION OF DEVICE CLICKING, IT IS REASONABLE TO LINK THE GIVING WAY EVENT AS A CAUSE OF THE MALFUNCTION.

    Additional Manufacturer Narrative · 0

    THIS EVENT IS BEING REPORTED DUE TO THE DEVICE REMOVAL SCHEDULED AS A RESULT OF THE DEVICE MALFUNCTION. ONCE EXPLANTED AND RETURNED, AND THE INVESTIGATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    THIS SUPPLEMENTAL REPORT IS BEING PROVIDED DUE TO THE DEVICE REMOVAL WHICH TOOK PLACE AFTER THE INITIAL REPORT OF DEVICE MALFUNCTION WAS SUBMITTED. CLINICAL TRIAL PATIENT IN EUROPE EXPERIENCED AN EPISODE OF THE KNEE GIVING WAY, CRACKING SOUND AND FELT CLICKING. ON EXAMINATION, THE PATIENT HAD SWELLING/HYDROPS, RETROPATELLAR CREPITATIONS DURING MOBILIZATION, NO MEDIAL/LATERAL OR AP KNEE INSTABILITY AND FULL RANGE OF MOTION. X-RAY SHOWED DEVICE MALFUNCTION. THE PATIENT REPORTED KNEE GIVING WAY EXPERIENCES PRIOR TO AND AFTER DEVICE IMPLANTATION, AND IMMEDIATELY PRECEDING THE EVENT. DEVICE WAS REMOVED APPROXIMATELY A MONTH LATER. THE EVENT RESOLVED, PATIENT REPORTED TO BE DOING WELL WITH SLIGHT MEDIAL SWELLING AND FULL RANGE OF MOTION.

    Description of Event or Problem · 0

    CLINICAL TRIAL PATIENT IN EUROPE EXPERIENCED A CRACKING SOUND AND FELT CLICKING. ON EXAMINATION, THE PATIENT HAD SWELLING/HYDROPS, RETROPATELLAR CREPITATIONS DURING MOBILIZATION. KNEE REMAINS STABLE WITH FULL RANGE OF MOTION. X-RAY SHOWED DEVICE MALFUNCTION. DEVICE REMOVAL IS SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2424840 MISHA KNEE SYSTEM IMPLANTED SHOCK ABSORBER QVV MOXIMED, INC. 18102405 00856047005795

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Male Required Intervention