BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN FEMORAL HEAD

    MDR report key: 8459003 · Received March 28, 2019

    Report

    Report Number
    3002806535-2019-00315
    Event Type
    Injury
    Date Received
    March 28, 2019
    Report Date
    March 28, 2019
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JDI
    PMA / PMN Number
    NI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE, FOREIGN - EVENT OCCURRED IN THE (B)(6). 'UNCEMENTED HEMIARTHROPLASTY FOR FRACTURED NECK OF FEMUR: A CONSECUTIVE SERIES WITH A SINGLE PROSTHESIS' BY JONATHAN R.B. HUTTT, OSAMA AWELD, ARSHAD KHALEEL (2011). DOI 10.1007/S00590-010-0742-1. THE PRODUCT AND LOT NUMBER IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY AND THE COMPLAINT HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT CONCLUSION AS TO THE CAUSE OF THE EVENT. 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. [(B)(4)]. PRODUCT NOT RETURNED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED IN A JOURNAL ARTICLE THAT 2 PATIENTS UNDERWENT HIP REVISION SURGERIES DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252519 UNKNOWN FEMORAL HEAD HIP PROSTHESIS JDI BIOMET UK LTD. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R