BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALACOS R 1X 40G SINGLE

    MDR report key: 4553394 · Received February 25, 2015

    Report

    Report Number
    1526350-2015-00034
    Event Type
    Injury
    Date Received
    February 25, 2015
    Date of Event
    November 21, 2014
    Report Date
    January 27, 2015
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    LOD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER; HOWEVER THE INVESTIGATION WAS NOT COMPLETED AT THE TIME OF THIS REPORT. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION TKS FOR PAIN AND AESEPTIC LOOSENING, POTENTIALLY DUE TO A NICKEL ALLERGY DISCOVERED POST OP. THE DEPUY DEMORIAL AND TIBIAL COMPONENT WERE GROSSLY LOOSE AND EASILY REMOVED. THERE WAS NOT ANY PALACOS CEMENT REMAINING ON EITHER METAL COMPONENT BUT A PRISTINE CEMENT REMAINING ON EITHER METAL COMPONENT BUT A PRISTINE CEMENT MANTLE WITH PERFECT IMPRESSIONS OF THE IMPLANTS REMAINED ON THE BONE SURFACES UPON COMPONENT REMOVAL. THE CEMENT WAS ALSO EASILY REMOVED SINCE IT CAME OUT ABNORMALLY IN LARGE CHUNKS. IT WAS FOUND THERE TO BE A FUNNY FIBROUS TISSUE AT THE BONE/CEMENT INTERFACE THAT IS NOT TYPICALLY FOUND IN REVISION SCENARIOS. IT APPEARED THAT THE CEMENT DID NOT ADHERE TO EITHER THE BONE OR THE IMPLANT ALL THAT WELL. THE REPORTER WAS CURIOUS ABOUT WHAT MAY HAVE BEEN THE CAUSE OF THIS AND IF THE CEMENT MAY HAVE CONTRIBUTED TO THIS EFFECT. THE PROCEDURE WAS COMPLETED WITH ANOTHER PRODUCT. THERE WAS NO REPORT OF ANY EXTENSION/DELAY IN THE SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131297 PALACOS R 1X 40G SINGLE PALACOS R 1X 40G SINGLE LOD ZIMMER SURGICAL 75164315

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR