BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM

    MDR report key: 3161942 · Received May 29, 2013

    Report

    Report Number
    3005985723-2013-00032
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 29, 2013
    Manufacturer
    MAKO SURGICAL
    Product Code
    NPJ
    PMA / PMN Number
    K090763
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT WAS CONTACTED TO PROVIDE THE INFO HE REQUESTED REGARDING ALTERNATE SURGEONS IN HIS AREA. THE PT DID NOT PROVIDE SPECIFIC INFO ABOUT HIS ORIGINAL CASE TO ALLOW FURTHER INVESTIGATION. THERE WAS NO ALLEGATION FROM THE PT AND NO INDICATION THAT MAKO PRODUCTS CONTRIBUTED TO THE INJURY.

    Description of Event or Problem · 1

    (B)(6) IS THE PT WHO CALLED IN ON (B)(6) 2013 TO COMPLAIN ABOUT HIS MAKOPLASTY PROCEDURE DONE IN (B)(6) 2010. IT STARTED BOTHERING HIM A FEW MONTHS AFTER HIS SURGERY. THE ORIGINAL SURGEON HAD LEFT (B)(6) BY THAT TIME SO HE SAW A DIFFERENT SURGEON WHO TOLD HIM "TO LIVE WITH IT". THE SURGEON TOLD HIM THAT IT SHOULD NOT HAVE BEEN DONE IN THE FIRST PLACE. HE SAID HIS CURRENT SURGEON TOLD HIM HE'S GOING TO HAVE TO GIVE HIM A TOTAL KNEE REPLACEMENT WHICH HE DOES NOT WANT. HE SAID HIS KNEE IS UNUSABLE RIGHT NOW AND IS SIGNIFICANTLY AFFECTING HIS LIFE. HE ORIGINALLY CALLED IN TO FIND OUT WHO IN HIS AREA IS ANOTHER MAKOPLASTY SURGEON SO HE CAN GO FOR A 2ND OPINION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234129 RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM COMPARTMENTAL KNEE PROSTHESIS SYSTEM NPJ MAKO SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1