BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    36MM COCR MOD HD STD

    MDR report key: 11197325 · Received January 19, 2021

    Report

    Report Number
    0001825034-2021-00115
    Event Type
    Malfunction
    Date Received
    January 19, 2021
    Date of Event
    January 5, 2021
    Report Date
    April 15, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    UDI-DI
    00887868307959
    PMA / PMN Number
    K032396
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. ONE 36MM COCR MOD HD STD ITEM# 11-363662 LOT# 706880 WAS RETURNED AND EVALUATED. UPON VISUAL INSPECTION THERE IS NO VISIBLE DAMAGE TO THE DEVICE EITHER IN THE TAPER OR ON THE OUTSIDE DIAMETER. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. MEDICAL RECORDS WERE NOT PROVIDED. RADIOGRAPHS WERE RECEIVED AND IDENTIFIED THAT IMAGES ARE OF LEFT HIP PREPLANNING IMAGE AND ONE OF IMMEDIATE POST IMPLANT. AS THE COMPLAINT IS FOR ISSUES WITH HEAD AND TAPER DURING IMPLANTATION, NEITHER OF THESE IMAGES WOULD ASSIST IN THE INVESTIGATION, THEREFOR IMAGES WILL NOT BE SUBMITTED FOR REVIEW. A DEFINITIVE ROOT CAUSE CANNOT 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 DEVICES: ITEM# 12-151413 ITEM NAME: ECHO HIP FX LAT FEMORAL 13MM LOT# 623710; ITEM# 110010245 ITEM NAME: G7 OSSEOTI 4 HOLE SHELL 54MM F LOT# 6833713; ITEM# 30123606 ITEM NAME: G7 VIT E HIGH WALL LNR 36MM F LOT# 64797292. PRODUCT HAS BEEN RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN INITIAL HIP ARTHROPLASTY WHEN THE SURGEON IMPACTED FEMORAL HEAD ONTO FEMORAL STEM, THE IMPLANT DID NOT ENGAGE TAPER. A NEW HEAD WAS OPENED AND UTILIZED AND NEW HEAD ENGAGED ONTO SAME STEM. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88858 36MM COCR MOD HD STD PROSTHETIC, HIP JDI ZIMMER BIOMET, INC. N/A 706880 00887868307959

    Patients

    Seq Age Sex Outcome Treatment
    1