BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN 18040X MCK PFJ SIZE UNKNOWN

    MDR report key: 7451374 · Received April 23, 2018

    Report

    Report Number
    0002249697-2018-01208
    Event Type
    Malfunction
    Date Received
    April 23, 2018
    Date of Event
    March 27, 2018
    Report Date
    April 23, 2018
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A SURGEON AND MENTIONED THAT HE HAS BEEN HAVING TROUBLE WITH THE MAKO MCK PFJ IMPLANT. HIS PATIENTS HAVE BEEN COMING INTO CLINIC WITH SQUEAKING AND AUDIBLE CREPITUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292773 UNKNOWN 18040X MCK PFJ SIZE UNKNOWN KNEE IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other