BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN OXFORD KNEE

    MDR report key: 4900138 · Received July 8, 2015

    Report

    Report Number
    0001825034-2015-02870
    Event Type
    Malfunction
    Date Received
    July 8, 2015
    Report Date
    November 2, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PUNKNOWN
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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. (B)(6). THIS INFORMATION WAS ORIGINALLY REPORTED ON 1825034-2015-02954 WHICH REFERENCED A JOURNAL ARTICLE WRITTEN ON A STUDY THAT THIS PATIENT TOOK PART IN.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE TITLED, "OXFORD MEDIAL UNICOMPARTMENTAL KNEE ARTHROPLASTY", WHICH DESCRIBED THE OUTCOME OF A SERIES OF 124 OXFORD MENISCAL-BEARING UNICOMPARTMENTAL ARTHROPLASTIES CARRIED OUT FOR OSTEOARTHRITIS OF THE MEDIAL COMPARTMENT, USING THE OXFORD KNEE MANUFACTURED AT BIOMET. IT WAS REPORTED THAT PATIENT UNDERWENT A PARTIAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, PATIENT WAS REVISED ON AN UNKNOWN DATE DUE TO A DISLOCATED BEARING. ALL COMPONENTS WERE REMOVED AND REPLACED WITH A TOTAL KNEE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443298 UNKNOWN OXFORD KNEE PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R