BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_MAKO_PRODUCT

    MDR report key: 4878961 · Received June 30, 2015

    Report

    Report Number
    3005985723-2015-00119
    Event Type
    Injury
    Date Received
    June 30, 2015
    Date of Event
    May 22, 2015
    Report Date
    June 4, 2015
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS AN UNKNOWN MAKO PRODUCT. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED IN THE PATIENT AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    PATIENT CALLED STATING THAT HE HAS KNEE PAIN ON (B)(6). PATIENT IS UNSURE IF HE'S BEEN IMPLANTED WITH A MAKOPLASTY KNEE. IT WAS FURTHER REPORTED THE PATIENT STATES THAT OTHER SURGEONS AND CLINICS REFUSE TO SEE HIM FOR HIS KNEE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423922 UNKNOWN_MAKO_PRODUCT IMPLANT JWH MAKO SURGICAL CORP. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other