BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS

    MDR report key: 4381181 · Received December 22, 2014

    Report

    Report Number
    3005985723-2014-00209
    Event Type
    Injury
    Date Received
    December 22, 2014
    Date of Event
    November 13, 2014
    Report Date
    November 26, 2014
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    KRR
    PMA / PMN Number
    K112507
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF NORMAL COMPLAINT FOLLOW UP, AN EVAL OF THE EVENT WAS COMPLETED AT MAKO SURGICAL. A SUPPLEMENTAL REPORT WILL BE FILED WHEN ADDITIONAL INFO IS OBTAINED.

    Description of Event or Problem · 1

    THE SURGEON PERFORMED A PARTIAL KNEE ARTHROPLASTY PROCEDURE ON (B)(6) 2014 USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND RESTORIS MULTICOMPARTMENTAL KNEE (MCK) IMPLANTS. THE SURGEON STATED TO A MAKOPLASTY SPECIALIST THAT DURING THE SURGERY THE TIPS OF THE BONE PINS "SHEARED OFF" DURING INSERTION OF THE PINS. THE BROKEN TIPS OF THE BONE PINS REMAINED EMBEDDED IN THE PT'S TIBIA POST OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843062 RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS KRR MAKO SURGICAL CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO)