BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEMORAL HEAD PROVISIONAL

    MDR report key: 10710524 · Received October 21, 2020

    Report

    Report Number
    0001822565-2020-03557
    Event Type
    Malfunction
    Date Received
    October 21, 2020
    Date of Event
    September 23, 2020
    Report Date
    March 9, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT SAMPLE WAS RETURNED AND EVALUATED AGAINST THE REPORTED EVENT. VISUAL REVIEW OF THE DEVICES SHOWED THE PROVISIONAL HEAD STILL ATTACHED TO THE STEM. NICKS AND SCRATCHES WERE NOTED TO THE SPHERICAL SURFACE INDICATED USE. NO OTHER DAMAGE WAS NOTED. STEM SHOWS GOUGES ON THE SIDES OF THE NECK. NO OTHER DAMAGES WERE NOTED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE ROOT CAUSE IS 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 PRODUCT: 574102030; AVENIR COMPLETE STEM; 3023168. PRODUCT HAS BEEN RECEIVED AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565 - 2020 - 03555.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INITIAL HIP PROCEDURE, THE HEAD TRIAL WAS COLD WELDED TO THE AVENIR STEM IMPLANT. THE SURGEON WAS UNABLE TO REMOVE THE HEAD TRIAL, AND HAD TO EXPLANT THE 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
    1176533 FEMORAL HEAD PROVISIONAL HIP INSTRUMENT FZX ZIMMER BIOMET, INC. N/A 64810953

    Patients

    Seq Age Sex Outcome Treatment
    1