BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN OXFORD TIBIAL COMPONENT

    MDR report key: 6789469 · Received August 11, 2017

    Report

    Report Number
    3002806535-2017-00787
    Event Type
    Injury
    Date Received
    August 11, 2017
    Date of Event
    September 10, 2016
    Report Date
    August 11, 2017
    Manufacturer
    BIOMET UK LTD.
    Product Code
    HRY
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).CONCOMITANT MEDICAL PRODUCTS: UNKNOWN OXFORD BEARING, UNKNOWN OXFORD FEMORAL. INITIAL REPORTER: MATTHIJS P. SOMFORD, REINOUD W. BROUWER, PIETER-STIJN W.A. HAEN, JOS J.A.M. VAN RAAY, AND TOM M. VAN RAAIJ ¿TECHNICAL ASPECTS OF REVISION AND FUNCTIONAL OUTCOME AFTER REVISION OF THE OXFORD UNICOMPARTMENTAL KNEE ARTHROPLASTY¿ THE KNEE 23 (2016) 1020-1023. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. A DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. A COMPLAINT HISTORY REVIEW WAS UNABLE TO BE PERFORMED AS THE PART AND LOT NUMBERS ARE UNKNOWN. A ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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. PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE THAT SIX PATIENTS WERE REVISED TO ADDRESS MALPOSITIONING OF THE TIBIAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567959 UNKNOWN OXFORD TIBIAL COMPONENT PROSTHESIS, KNEE HRY BIOMET UK LTD. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R