BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BIOMET AVANTAGE INSERT

    MDR report key: 6335106 · Received February 16, 2017

    Report

    Report Number
    3006946279-2017-00035
    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. ITEM #UNK, UNKNOWN STEM, LOT #UNK; ITEM #UNK, UNKNOWN HEAD, LOT #UNK. 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 PATIENT UNDERWENT HIP REVISION PROCEDURE APPROXIMATELY TWO YEARS POST-IMPLANTATION DUE TO RECURRENT DISLOCATION AND COMPONENT MAL-ALIGNMENT. ALL ACETABULAR COMPONENTS WERE REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118595 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