BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAKO SURGICAL CORPORATION

    MDR report key: 2303276 · Received October 17, 2011

    Report

    Report Number
    MW5022696
    Event Type
    Injury
    Date Received
    October 17, 2011
    Date of Event
    November 9, 2009
    Report Date
    October 17, 2011
    Manufacturer
    MAKO SURGICAL CORPORATION
    Product Code
    OLO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IMPLANTATION OF UNICOMPARTMENT KNEE REPLACEMENT MANUFACTURED BY MAKO SURGICAL CORPORATION. PENDING (B)(6) SUPERIOR COURT, PRODUCT DEFECT COMPLAINT FILED. FDA APPROVAL WAS OBTAINED BASED ON "SUBSTANTIALLY SIMILAR" DEVICES. THE DEVICE AND PROCESS BY WHICH THE DEVICE IS IMPLANTED HAS CAUSED MUCH INJURY AND PROBLEMS AND RE-EVALUATION OF ITS APPROVAL FOR USE SHOULD BE INVESTIGATED. TWO SUBSEQUENT "CORRECTIVE SURGERIES" HAVE NOT SALVAGED THE PROSTHETIC AND A TOTAL KNEE REPLACEMENT IS LIKELY. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAKO SURGICAL CORPORATION MAKOPLASTY OLO MAKO SURGICAL CORPORATION DOC

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| O| R| S