BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LINER

    MDR report key: 8645322 · Received May 28, 2019

    Report

    Report Number
    0001825034-2019-02328
    Event Type
    Injury
    Date Received
    May 28, 2019
    Date of Event
    April 2, 2019
    Report Date
    August 19, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HTW
    PMA / PMN Number
    NI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED WITH OPERATIVE NOTES PROVIDED. OPERATIVE NOTES DEMONSTRATED THAT THE PATIENT HAD I & D SURGERY BEFORE DEEP INFECTION WAS IDENTIFIED, AND IT WAS DETERMINED THAT NOT ONLY THE HEAD AND LINER, BUT ALSO THE CUP AND STEM NEEDED REVISED. DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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 PRODUCTS: BIOMET G7 SHELL CAT#010000662 LOT#6395394, BIOMET STEM CAT#192808 LOT# 668350, BIOMET TAPER SLEEVE CAT#650-1064 LOT#2955104, BIOMET HEAD CAT#650-1057 LOT#2955098, ZIMMER BONE SCREW CAT#00625006530 LOT#64228001, BIOMET LINER CAT#010000817 LOT#6354149. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2019 - 02327, 0001825034 - 2019 - 02329.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT PRIMARY LEFT THA. SUBSEQUENTLY, THE PATIENT WAS ADMITTED TO THE HOSPITAL APPROXIMATELY 2 MONTHS POST IMPLANTATION DUE TO INFECTION WHERE PATIENT UNDERWENT A TWO-STAGE REVISION SECONDARY TO THE PRESENCE OF (B)(6). 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
    438806 UNKNOWN LINER PROSTHESIS, HIP HTW ZIMMER BIOMET, INC. N/A 949630

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R