BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MISHA KNEE SYSTEM

    MDR report key: 19761870 · Received July 17, 2024

    Report

    Report Number
    3008274656-2024-00002
    Event Type
    Injury
    Date Received
    July 17, 2024
    Date of Event
    June 17, 2024
    Report Date
    July 17, 2024
    Manufacturer
    MOXIMED, INC.
    Product Code
    QVV
    UDI-DI
    00856047005801
    PMA / PMN Number
    DEN220033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT DATE IS NOT KNOWN. THE DATE OF AWARENESS OF THE EVENT IS REPORTED AS THE EVENT DATE. THE MISHA KNEE SYSTEM WAS REPORTED TO BE WELL FIXATED AND FUNCTIONING AT THE TIME OF REMOVAL. THE REMOVAL WAS COMPLETED WITHOUT COMPLICATION. WOUND CULTURES INDICATED S. AUREUS INFECTION. A REVIEW OF MANUFACTURING RECORDS INDICATES THAT THE PRODUCT CONFORMED TO DESIGN AND MANUFACTURING SPECIFICATIONS. ANALYSIS OF THE RETURNED DEVICE FOUND IT TO BE INTACT AND WELL-FUNCTIONING. THE SOURCE OF THE INFECTION IS UNKNOWN. OF NOTE, AT THE TIME OF MISHA IMPLANTATION, ADDITIONAL PROCEDURES OF MENISCAL ALLOGRAFT, ACL CYST REMOVAL AND BONE MARROW ASPIRATE INJECTION WERE PERFORMED.

    Description of Event or Problem · 0

    PATIENT UNDERWENT MISHA IMPLANTATION FOR OA WITH CONCOMITANT MENISCAL ALLOGRAFT, ACL CYST REMOVAL AND BONE MARROW ASPIRATE INJECTION. APPROXIMATELY 4 MONTHS LATER, THE PATIENT PRESENTED WITH A SURGICAL SITE INFECTION WITH DISCHARGE FROM THE DISTAL END OF THE INCISION, REDNESS AND SWELLING. IRRIGATION AND DEBRIDEMENT OF THE WOUND WAS PERFORMED WITH REMOVAL OF THE MISHA DEVICE AND PLANNED POST-OP ORAL ANTIBIOTICS. AT THE POST-OP VISIT A WEEK LATER, THE PATIENT'S WOUND WAS WELL-HEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2147571 MISHA KNEE SYSTEM IMPLANTED SHOCK ABSORBER QVV MOXIMED, INC. 23032902 00856047005801

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Male Required Intervention BONE MARROW ASPIRATE CONCENTRATE INJECTION| DEBRIDEMENT OF ANTERIOR ACL CYST| MEDIAL MENISCUS TRANSPLANT