BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS

    MDR report key: 4208649 · Received October 21, 2014

    Report

    Report Number
    3005985723-2014-00177
    Event Type
    Injury
    Date Received
    October 21, 2014
    Date of Event
    September 27, 2014
    Report Date
    September 27, 2014
    Manufacturer
    MAKO SURGICAL
    Product Code
    KRR
    PMA / PMN Number
    K090763
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING IS A SUPPLEMENTAL REPORT TO THE ORIGINAL MDR SUBMITTED PREVIOUSLY. ADDITIONAL INFORMATION REGARDING THE EVENT IS PROVIDED HEREIN. SYSTEM DATA REVIEWED AND DAT SUGGESTS THE SYSTEM OPERATED AS EXPECTED. NO EVIDENCE OF SYSTEM MALFUNCTION. FEMORAL FRACTURE LIKELY CAUSED DUE TO STRESS CONCENTRATION FROM BONE PIN HOLES & SOFT BONE QUALITY DUE TO PATIENTS RA CONDITION.

    Additional Manufacturer Narrative · 1

    AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION OF THE EVENT HAS BEEN CONDUCTED BY MAKO SURGICAL. NO FURTHER INFO IS KNOWN AT THIS TIME. INVESTIGATION IS ONGOING, AND A SUPPLEMENTAL REPORT WILL BE FILED WHEN RESULTS ARE OBTAINED.

    Description of Event or Problem · 1

    THE SURGEON HAD PERFORMED A PARTIAL KNEE ARTHROPLASTY PROCEDURE USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND RESTORIS MULTICOMPARTMENTAL KNEE IMPLANTS ON (B)(6) 2014. POST OPERATIVE X-RAYS SHOWED ACCURATE COMPONENT PLACEMENT. THE PT LATER COMPLAINED ON PAIN MID-THIGH. ANOTHER X-RAY WAS PERFORMED WHICH SHOWED A FEMUR FRACTURE ALONG THE PIN-HOLE ENTRY SITES. THE SURGEON COMMENTED THAT THE PT HAS RHEUMATOID ARTHRITIS AND VERY SOFT BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670248 RESTORIS MULTICOMPARTMENTAL KNEE PROSTHESIS COMPARTMENTAL KNEE PROSTHESIS KRR MAKO SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 05/31/1 Required Intervention