BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTINUUM® TRILOGY® ALLOFIT® VIVACIT-E®

    MDR report key: 7210339 · Received January 22, 2018

    Report

    Report Number
    0001822565-2018-00320
    Event Type
    Injury
    Date Received
    January 22, 2018
    Date of Event
    December 17, 2017
    Report Date
    February 2, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK120370
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE REPORTS: 0001822565-2018-00319. 0001822565-2018-00321. CONCOMITANT MEDICAL PRODUCTS: 00875705601 SHELL WITH CLUSTER HOLES POROUS 56 MM O.D LOT 62522412, 00771101220 FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED PRESS-FIT CEMENTLESS SIZE 12.5 EXTENDED OFFSET LOT 62427984, 00877503603 BIOLOX® DELTA, CERAMIC FEMORAL HEAD, L, ø 36/+3.5, TAPER 12/14 LOT 2712175. REPORTED EVENT WAS UNABLE TO BE CONFIRMED. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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. DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE: CORRECTED: COMMON DEVICE NAME. PRODUCT CODE - OQG. 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 THE PATIENT EXPERIENCED PAIN IN RIGHT HIP. NO REVISION HAS BEEN REPORTED TO DATE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52967 CONTINUUM® TRILOGY® ALLOFIT® VIVACIT-E® HIP PROSTHESIS, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER, + ADDITIVE, POROUS JDI ZIMMER BIOMET, INC. N/A 62502288

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other