BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN OXFORD TIBIAL COMPONENT

    MDR report key: 6778277 · Received August 9, 2017

    Report

    Report Number
    3002806535-2017-00648
    Event Type
    Injury
    Date Received
    August 9, 2017
    Date of Event
    May 10, 2017
    Report Date
    August 9, 2017
    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
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE, FOREIGN ¿ EVENTS OCCURRED IN (B)(6). REPORT SOURCE, LITERATURE - XUE, H. ET AL (2017). UP TO TWELVE YEAR FOLLOW-UP OF THE OXFORD PHASE THREE UNICOMPARTMENTAL KNEE REPLACEMENT IN CHINA: SEVEN HUNDRED AND EIGHT KNEES FROM AN INDEPENDENT CENTRE. INTERNATIONAL ORTHOPAEDICS, 41(8), 1571¿1577. DOI 10.1007/S00264-017-3492-4. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED IN A JOURNAL ARTICLE THAT A PATIENT UNDERWENT A REVISION SURGERY DUE TO TIBIAL FRACTURE APPROXIMATELY 0.5 YEARS POST-IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560372 UNKNOWN OXFORD TIBIAL COMPONENT PROSTHESIS, KNEE NRA BIOMET UK LTD. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R