BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALANCE MICROP STEM 12X80MM RT

    MDR report key: 7149477 · Received December 27, 2017

    Report

    Report Number
    0001825034-2017-11449
    Event Type
    Injury
    Date Received
    December 27, 2017
    Date of Event
    May 15, 2017
    Report Date
    January 15, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK050251
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCTS: M2A 1 PC SHELL 38MMX54MM, CAT: 15-105054, LOT 532150; M2A 38MM MOD HD -3MM NK, CAT: 11-173661, LOT: 777660. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE THE SURGEON HAD DIFFICULTY REMOVING THE STEM, WHICH RESULTED IN A TROCHANTERIC OSTEOTOMY. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    929242 BALANCE MICROP STEM 12X80MM RT PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 186310

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other