BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LGN PS HIGH FLEX XLPE SZ 1-2 13MM

    MDR report key: 6776656 · Received August 9, 2017

    Report

    Report Number
    1020279-2017-00607
    Event Type
    Injury
    Date Received
    August 9, 2017
    Date of Event
    May 24, 2017
    Report Date
    May 3, 2018
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    PMA / PMN Number
    K071071
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE REVIEW ATTACHED FOR THE INVESTIGATION RESULTS.

    Additional Manufacturer Narrative · 1

    THE ASSOCIATED DEVICES WERE NOT RETURNED FOR EVALUATION. BASED ON THE AVAILABLE INFORMATION, THE ROOT CAUSE OF THE POLYETHYLENE LINER EXCHANGE WAS SECONDARY TO A DISLOCATION. HOWEVER, THE CAUSE OF THE DISLOCATION CANNOT BE CONCLUDED. ALL DOCUMENTS AND IMAGES PROVIDED AS OF THIS DATE HAVE BEEN REVIEWED AND CONSIDERED AND UNLESS NOTED DO NOT CONTRIBUTE TO THE CLINICAL INVESTIGATION. SHOULD ANY RELEVANT CLINICAL/MEDICAL INFORMATION BECOME AVAILABLE THESE COMPLAINTS CAN BE RE-ASSESSED. A REVIEW OF MANUFACTURING RECORDS DID NOT REVEAL ANY DEVIATIONS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. A REVIEW OF MANUFACTURING RECORDS REVEALED THAT WE HAVE NOT HAD ANY PREVIOUS COMPLAINTS FOR THE LISTED LOTS. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. IF ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. WE CONSIDER THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICE 510KS: K112941, K951987.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION OF POLY. POLY WAS REMOVED AND REPLACED WITH SAME SIZE POLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558881 LGN PS HIGH FLEX XLPE SZ 1-2 13MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH SMITH & NEPHEW, INC. 15FM13089

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R