BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER TOTAL KNEE SOLUTION

    MDR report key: 5903687 · Received August 23, 2016

    Report

    Report Number
    MW5064337
    Event Type
    Injury
    Date Received
    August 23, 2016
    Date of Event
    September 17, 2014
    Report Date
    August 15, 2016
    Manufacturer
    ZIMMER/BIOMET
    Product Code
    MBH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    AS OF THIS DAY: (B)(6) 2016: I WAS SEEN AT (B)(6) HOSPITAL; (B)(6), FOR A STRANGE GROWTH THAT APPEARED ON THE OUTSIDE OF MY LEFT IMPLANT [ZIMMER LPS-FLEX]. IT WAS THE SHAPE OF AN EGG. STAFF WAS OUT DONE AND COULD NOT EXPLAIN; AT THAT TIME NO XRAYS HAD BEEN DONE. ONCE THE XRAYS AND THE ULTRASOUND WERE DONE I LEFT. NOT WANTING TO HEAR THE SAME THING AGAIN I LEFT. "GO SEE THE MD THAT PUT THEM IN". DR. (B)(6) OF (B)(6) HAS SAID THERE'S NOTHING WRONG FOR TWO YEARS OR MORE. SINCE INSTALLATION OF THESE UNITS THERE HAVE BEEN NOTHING BUT: 24 HOUR PAIN, CRACKING SOUNDS, INSTABILITY, ANXIETY, AS WELL AS A CONSTANT FEAR OF FALLING AND REALLY HURTING MYSELF. I STILL HAVE THE PRODUCT IN MY POSSESSION: YES. THE PRODUCT WAS DAMAGED BEFORE THE INCIDENT: YES. THE DAMAGE WAS REPAIRED PRIOR TO THE INCIDENT: NO. THE PRODUCT WAS MODIFIED BEFORE THE INCIDENT: NO. EXPLANATION: FAULTY PARTS. MAY WE INCLUDE YOUR REPORT: YES. YOU MAY INCLUDE MY REPORT WITH ANY ATTACHMENTS ON (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550851 ZIMMER TOTAL KNEE SOLUTION ZIMMER LPS-FLEX LCCK MBH ZIMMER/BIOMET LPS-FLEX TOTAL KNEE SOLUTION

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR