BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOM 28MM RNGLOC LNR HWALL 23

    MDR report key: 8184236 · Received December 20, 2018

    Report

    Report Number
    0001825034-2018-11410
    Event Type
    Injury
    Date Received
    December 20, 2018
    Report Date
    February 11, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K023357
    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 · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF RADIOGRAPHS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM#: 163663, 28MM DIA COCR MOD HD +3MM NK, LOT#: 963610, ITEM#: 162254, BI-METRIC POROUS FMRL 14X150MM, LOT#: 823940, ITEM#: 11-103558, UNIV RNGLC SHL 58MM/L23, LOT#: 120800, ITEM#: 113845, TITANIUM SCREW LOW PROF 5X25MM, LOT#: 033480. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT RIGHT HIP ARTHROPLASTY APPROXIMATELY 15 YEARS AGO. SUBSEQUENTLY, THE PATIENT IS BEING CONSIDERED FOR A REVISION DUE TO POLY WEAR ON AN UNKNOWN DAY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1022874 ARCOM 28MM RNGLOC LNR HWALL 23 HIP PROSTHESIS LPH ZIMMER BIOMET, INC. N/A 800200

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention