BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZIMMER PATIENT SPECIFIC INSTRUMENT

    MDR report key: 3168307 · Received June 11, 2013

    Report

    Report Number
    3005718816-2013-00006
    Event Type
    Other
    Date Received
    June 11, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 14, 2013
    Manufacturer
    MATERIALISE NV
    Product Code
    MBH
    PMA / PMN Number
    K121640
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION FOR A ROOT CAUSE IS IN PROGRESS. AS SOON AS THE INVESTIGATION IS CONCLUDED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A BILATERAL TOTAL KNEE REPLACEMENT WHERE EACH SIDE WAS GUIDED BY THE DEVICE. THE KNEE WAS CUT IN VALGUS ON BOTH SIDES AND THE FEMUR GUIDE DID NOT FIT. THE PHYSICIAN CONTINUED WITH TRADITIONAL INSTRUMENTATION. THE EVENT CAUSED A DELAY OF 8 HOURS. NO INJURY OR SIGNIFICANT BLOOD LOSS WAS REPORTED. THE PHYSICIAN REPORTED THERE WAS NO HARM OR INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263919 ZIMMER PATIENT SPECIFIC INSTRUMENT MBH, JWH MBH MATERIALISE NV 00-5970-000-29 56543949

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other