BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA INSERT 36MM 54-56MM SHELL

    MDR report key: 5741324 · Received June 22, 2016

    Report

    Report Number
    3002806535-2016-00376
    Event Type
    Injury
    Date Received
    June 22, 2016
    Date of Event
    May 15, 2016
    Report Date
    October 8, 2016
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS USER FACILITY IS OUTSIDE OF THE UNITED STATES. THE NECESSARY MANUFACTURING HISTORY WAS NOT PROVIDED FOR REVIEW. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE FOLLOWING COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED: DEVICE INFO - EXPIRATION DATE NI, INITIAL REPORTER - NAME NI, MANUFACTURE DATE ¿ NI. 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 K051411.

    Additional Manufacturer Narrative · 1

    UPON REVIEW OF THE REPORTED EVENT, IT WAS DETERMINED TO NOT BE REPORTABLE AS THIS DEVICE IS NOT CLEARED FOR DISTRIBUTION IN THE UNITED STATES, NOR DOES ZIMMER BIOMET IN THE U.S. MARKET OR MANUFACTURE A SIMILAR DEVICE. THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY THREE MONTHS POST-IMPLANTATION DUE TO AUDIBLE NOISE AND RADIOGRAPHS REVEALED THE CERAMIC INSERT HAD FRACTURED. SOME PIECES OF THE FRACTURED INSERT WERE RETAINED BY THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397257 BIOLOX DELTA INSERT 36MM 54-56MM SHELL PROSTHESIS, HIP LZO BIOMET UK LTD. N/A 2015051344

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R