BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRA DRIVE 5MM HOE

    MDR report key: 9883047 · Received March 26, 2020

    Report

    Report Number
    0001825034-2020-01303
    Event Type
    Malfunction
    Date Received
    March 26, 2020
    Date of Event
    March 3, 2020
    Report Date
    June 18, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDX
    UDI-DI
    00880304372979
    PMA / PMN Number
    K031280
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT SAMPLE WAS RETURNED AND EVALUATED AGAINST THE COMPLAINT. MULTIPLE DEVICES WERE RETURNED AND VISUAL INSPECTION OF ONE ITEM NUMBER 423859 WAS FRACTURED AND BLACKENED. THE SECOND ITEM NUMBER 423859 WAS INTACT BUT HAD BEEN BLACKENED WITH DEBRIS IN THE TIP. ITEM NUMBER 423864 HAD THE TIP WORN AND BLACKENED. ITEM NUMBER 423880 WAS RETURNED WITH THE TIP SHOWING DAMAGE AND DISCOLORATION. ITEM NUMBER 807910 WAS RETURNED FRACTURED INTO TWO PIECES. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. IT WAS DETERMINED THAT THE PRODUCT WORKED AS INTENDED AND WHAT IS SEEN TO BE NORMAL USE OF PRODUCT AND NO PROBLEM FOUND. 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 ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). PRODUCTS HAVE BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAVE BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2020-01301, 0001825034-2020-01302, 0001825034-2020-01304.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HIP PROCEDURE, THE PRODUCTS BENT, TWISTED AND FRACTURED DURING USE. IT IS UNKNOWN IF THERE WAS ANY HARM OR INJURY SUSTAINED BY THE PATIENT. 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
    347637 ULTRA DRIVE 5MM HOE HIP INSTRUMENT JDX ZIMMER BIOMET, INC. N/A 429470 00880304372979

    Patients

    Seq Age Sex Outcome Treatment
    1