BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER NEUTRAL 28 MM I.D. SIZE II FOR USE WITH 52 MM O.D. SIZE II SHELL

    MDR report key: 8008786 · Received October 26, 2018

    Report

    Report Number
    0001822565-2018-05900
    Event Type
    Injury
    Date Received
    October 26, 2018
    Date of Event
    September 18, 2013
    Report Date
    February 5, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K151448
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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 · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM # 00875505200, ALLOFIT® IT ALLOCLASSIC®, SHELL, LOT # 2702868; ITEM # 00877502802, BIOLOX® DELTA, CERAMIC FEMORAL HEAD, LOT # 2683287; ITEM # 0106010103, AVENIR® MüLLER, STEM, LOT # 4020467. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT SUFFERED A DISLOCATION APPROXIMATELY 16 DAYS POST IMPLANTATION. THE PATIENT UNDERWENT A CLOSED REDUCTION. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850687 LINER NEUTRAL 28 MM I.D. SIZE II FOR USE WITH 52 MM O.D. SIZE II SHELL HIP PROSTHESIS JDI ZIMMER BIOMET, INC. N/A 62325521

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R