BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 HI-WALL ARCOMXL LNR 36MM D

    MDR report key: 8648405 · Received May 28, 2019

    Report

    Report Number
    0001825034-2019-02337
    Event Type
    Injury
    Date Received
    May 28, 2019
    Date of Event
    April 4, 2019
    Report Date
    August 19, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K121874
    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. UDI# (B)(4). REPORTED EVENT WAS CONFIRMED WITH MEDICAL RECORDS AND X RAYS PROVIDED. MEDICAL RECORDS DEMONSTRATED I&D LEFT HIP WITH EXCHANGE OF FEMORAL HEAD AND LINER. THE SURGEON ENCOUNTERED SUPERFICIAL EFFUSION SEPARATE FROM DEEP STRUCTURES THAT WAS CULTURED. ALSO NOTED A DEEP THIGH ABSCESS OR EFFUSION WAS IN CONTACT WITH LEFT JOINT. CULTURES TAKEN NOTED DEEP THIGH ASPIRATE INFECTION WILL BE IN CONTACT WITH JOINT. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. 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. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, DUE TO LOCATION OF DEVICE IS UNKNOWN; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. 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: 0001825034 - 2019 - 02338.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT PRIMARY LEFT THA. SUBSEQUENTLY, THE PATIENT UNDERWENT AN I&D PROCEDURE APPROXIMATELY 2 MONTHS POST IMPLANTATION DUE TO INFECTION. IT WAS NOTED THE CERAMIC HEAD, LINER, SCREW AND TAPER WERE REMOVED. 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
    441215 G7 HI-WALL ARCOMXL LNR 36MM D PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 6354149

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R