BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IT VITE XLPE LINER

    MDR report key: 7327810 · Received March 9, 2018

    Report

    Report Number
    0001822565-2018-01343
    Event Type
    Injury
    Date Received
    March 9, 2018
    Date of Event
    February 11, 2018
    Report Date
    March 30, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    OQG
    PMA / PMN Number
    PK120370
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 0100351002, MS-30® LATERAL STEM, 2867473, 0100358010, MS-30® DISTAL CENTRALIZER, 2906879, 00877503603, BIOLOX® DELTA CERAMIC FEMORAL HEAD, 2903504, 00875705801, SHELL WITH CLUSTER HOLES POROUS 58 MM, 63764589, 00801102024, ALLEN PLUG HDPE/BASO4 12C/24FL, 63410861. REPORT SOURCE, FOREIGN - THE EVENT OCCURRED IN (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED . ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S HIP WAS REVISED DUE TO DISLOCATION TEN DAYS POST-IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169857 IT VITE XLPE LINER PROSTHESIS, HIP OQG ZIMMER BIOMET, INC. N/A 63703678

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R