BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BIOMET AVANTAGE INSERT

    MDR report key: 6335104 · Received February 16, 2017

    Report

    Report Number
    3006946279-2017-00034
    Event Type
    Injury
    Date Received
    February 16, 2017
    Report Date
    February 16, 2017
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    LPH
    PMA / PMN Number
    PNI
    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. AHMED NAGEEB MAHMOUD ET. ALL "AN ANALYSIS OF ONE HUNDRED FORTY-SEVEN REVISIONS AT A MEAN OF FIVE YEARS". THE JOURNAL OF ARTHROPLASTY (2016) 1E6. THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET IN (B)(4) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K101336.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE THAT 3 HIPS HAD CLOSED REDUCTIONS DUE TO DISLOCATION. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118593 UNKNOWN BIOMET AVANTAGE INSERT HIP PROSTHESIS LPH BIOMET FRANCE S.A.R.L. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R