BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN INSTERTER

    MDR report key: 14291968 · Received May 5, 2022

    Report

    Report Number
    0001825034-2022-01129
    Event Type
    Malfunction
    Date Received
    May 5, 2022
    Date of Event
    April 16, 2022
    Report Date
    May 12, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, H1, H2, H3, H6, H10 VISUAL EXAMINATION OF THE PROVIDED PICTURE IDENTIFIED THE TIP OF THE INSERTER IS FRACTURED. ADDITIONALLY THE DEVICE SHOWS SIGNS OF WEAR. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED.. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE ITEM AND LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE COULD NOT 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 · 0

    IT WAS REPORTED THAT DURING AN INITIAL HIP ARTHROPLASTY, THE TIP OF THE THREADED INSERTER FRACTURED. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2473212 UNKNOWN INSTERTER PROSTHESIS, HIP JDH ZIMMER BIOMET, INC. N/A N/I

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown