BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LINER

    MDR report key: 8459922 · Received March 28, 2019

    Report

    Report Number
    3002806535-2019-00322
    Event Type
    Injury
    Date Received
    March 28, 2019
    Report Date
    March 28, 2019
    Manufacturer
    BIOMET UK LTD.
    Product Code
    KWA
    PMA / PMN Number
    NI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (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). DEVICE EVALUATED BY MFR: PRODUCT NOT RETURNED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED IN A JOURNAL ARTICLE THAT 1 PATIENT UNDERWENT HIP REVISION SURGERY DUE TO DUE TO RECURRENT DISLOCATIONS CAUSED BY POOR QUALITY SOFT TISSUES TWO MONTHS AFTER INITIAL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253100 UNKNOWN LINER HIP PROSTHESIS KWA BIOMET UK LTD. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R