BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODULAR HEAD COMPONENT 32MM

    MDR report key: 7263496 · Received February 12, 2018

    Report

    Report Number
    0001825034-2018-00855
    Event Type
    Injury
    Date Received
    February 12, 2018
    Date of Event
    December 4, 2017
    Report Date
    February 10, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK911684
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: MFR# 0001825034-2017-11157. CONCOMITANT MEDICAL PRODUCTS: ARCOM 32 MM RLOC LNR 10D/HWL 23 PN11-105873 LN216780, MLRY-HD POR FMRL 11 X 160 MM PN11-104111 LN953130. REPORTED EVENT WAS CONFIRMED BY REVIEW OF PHOTOGRAPHS OF THE EXPLANTS, THAT SHOW THE LINER CRACKED AND BROKEN, BLACK DEBRIS NOTED ON COCR HEAD AND POLY LINER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. 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 WAS REVISED THIRTEEN YEARS POST IMPLANTATION DUE TO LINER WEAR. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106841 MODULAR HEAD COMPONENT 32MM PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 899590

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R