BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIBIAL INLAY IMPACTOR HEAD

    MDR report key: 5940655 · Received September 9, 2016

    Report

    Report Number
    3005985723-2016-00287
    Event Type
    Injury
    Date Received
    September 9, 2016
    Date of Event
    August 15, 2016
    Report Date
    August 15, 2016
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    NPJ
    PMA / PMN Number
    K090763
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE 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

    TIP OF MAKO PARTIAL KNEE TIBIAL BASEPLATE IMPACTOR (PART NUMBER 160177) WAS NOTED TO BE MISSING BY SCRUB NURSE FOLLOWING IMPLANT PLACEMENT. EXPLORATION OF WOUND PRIOR TO CLOSURE DID NOT REVEAL TIP. EXTENSIVE SEARCH OF DRAPES AND OR FOLLOWING CASE WAS PERFORMED AND TIP NOT FOUND. PATIENT X-RAYED WITH II, NOTHING OF NOTE SEEN BY SURGEON. PLAIN X-RAY TAKEN TO CHECK - SMALL AREA QUESTIONED BY SURGEON SO DECISION TO RE OPEN WOUND AND EXPLORE BACK OF KNEE. RE-EXPLORATION WITH ARTHROSCOPIC ASSISTANCE DID NOT REVEAL TIP. DELAY OF SURGERY APPROXIMATELY 60 MINUTES. RIGHT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592309 TIBIAL INLAY IMPACTOR HEAD PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM NPJ MAKO SURGICAL CORP. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention