BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN INSERT

    MDR report key: 6723824 · Received July 18, 2017

    Report

    Report Number
    0002249697-2017-02217
    Event Type
    Injury
    Date Received
    July 18, 2017
    Date of Event
    June 13, 2017
    Report Date
    July 18, 2017
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. NOT RETURNED.

    Description of Event or Problem · 1

    DR. N REPORTS PATIENT STATUS POST BILATERAL TRIATHLON KNEE REPLACEMENTS DONE ON (B)(6) 2016 HAS SOME INSTABILITY IN HIS LEFT KNEE AND DR. N WANTED TO REVISE THE KNEE TO A THICKER INSERT. THE LEFT KNEE WAS REVISED FROM A 13MM INSERT TO A 16MM CS INSERT . THE SURGERY WAS PERFORMED WITHOUT INCIDENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501640 UNKNOWN INSERT UNKNOWN - KNEE IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| O| R