BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVANTAGE INLAY SIZE 50/28

    MDR report key: 6175818 · Received December 15, 2016

    Report

    Report Number
    3006946279-2016-00462
    Event Type
    Malfunction
    Date Received
    December 15, 2016
    Date of Event
    November 9, 2016
    Report Date
    December 14, 2016
    Manufacturer
    BIOMET FRANCE S.A.R.L.
    Product Code
    LPH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. (B)(4). THIS DEVICE IS NOT CLEARED FOR DISTRIBUTION IN THE UNITED STATES; HOWEVER, THIS REPORT IS BEING FILED AS A SIMILAR DEVICE IS MANUFACTURED BY ZIMMER BIOMET IN THE US UNDER K101336.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, THE IMPLANT DID NOT MATCH THE LABEL ON THE PACKAGE. ANOTHER DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITHOUT SIGNIFICANT DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826211 AVANTAGE INLAY SIZE 50/28 PROSTHESIS, HIP LPH BIOMET FRANCE S.A.R.L. N/A 0001153944

    Patients

    Seq Age Sex Outcome Treatment
    1