BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN OXFORD KNEE

    MDR report key: 5830442 · Received July 28, 2016

    Report

    Report Number
    3002806535-2016-00593
    Event Type
    Death
    Date Received
    July 28, 2016
    Report Date
    June 28, 2016
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    PP010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED: BRAND NAME ¿ NI. DEVICE INFO - NI. INITIAL REPORTER - THE ARTICLE WAS WRITTEN BY OMAR K. ALNACHOUKATI, KEITH BEREND, MIKE KOLCZUN, ROGER EMERSON, ADOLF LOMBARDI, DAVID MAUERHAN, AND JOHN BARRINGTON. MANUFACTURE DATE ¿ NI. EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH SINCE THE LIMITED INFORMATION AVAILABLE INDICATES THAT A REVISION PROCEDURE MAY BE NECESSARY. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING A REVISION PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND, IF WARRANTED, FURTHER MEDWATCH REPORTS WILL BE SUBMITTED. PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF RAW DATA SPREADSHEETS AND JOURNAL ARTICLE ABSTRACT TITLED, "MULTI-CENTER STUDY OF 825 PHASE III OXFORD MEDIAL COMPARTMENTAL ARTHROPLASTY KNEES: AN AVERAGE TEN-YEAR SURVIVAL ANALYSIS IN THE UNITED STATES" WHICH AIMED TO PROVIDE THE FIRST LONG-TERM SURVIVORSHIP, LARGE PATIENT SAMPLE SIZE STUDY IN THE UNITED STATES LOOKING AT THE VARIOUS ASPECTS OF THE PHASE III OXFORD DESIGN WHILE ALSO ADDRESSING RECENT ADVANCEMENTS THAT CAN HELP AID THE UNICOMPARTMENTAL KNEE ARTHROPLASTY PROCESS AND IMPROVE PARTIAL KNEE SURVIVORSHIP. A PATIENT IDENTIFIED IN THE ARTICLE THAT UNDERWENT RIGHT PARTIAL KNEE ARTHROPLASTY REPORTEDLY EXPERIENCED PAIN APPROXIMATELY ELEVEN YEARS POST-IMPLANTATION. NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE. IT WAS FURTHER REPORTED THE PATIENT EXPIRED DUE TO UNKNOWN REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482209 UNKNOWN OXFORD KNEE PROSTHESIS, KNEE NRA BIOMET UK LTD. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death| O