BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 NEUTRAL E1 LINER 32MM D

    MDR report key: 8687433 · Received June 11, 2019

    Report

    Report Number
    0001825034-2019-02529
    Event Type
    Injury
    Date Received
    June 11, 2019
    Date of Event
    May 10, 2019
    Report Date
    August 23, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    PMA / PMN Number
    K121874
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UDI#: (B)(4). EVENT CONFIRMED WITH MEDICAL RECORDS RECEIVED. PATIENT PRESENTED TO PHYSICIAN¿S OFFICE WITH MILD WOUND DEHISCENCE, MEDICAL INTERVENTION NOTED, NO INDICATION OF INFECTION REPORTED. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. 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: G7 PPS LTD ACET SHELL# ITEM 010000662 LOT 6339725, BIOLOX® OPTION, HEAD # ITEM 00877703201 LOT 2784914, AVENIR® MüLLER, STEM # ITEM 0106010104 LOT 4023580. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-02530. 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 · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT MEDICAL INTERVENTION DUE TO POSTOP WOUND DEHISCENCE APPROXIMATELY 23 DAYS POST INITIAL SURGERY. NO FURTHER INFORMATION AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481186 G7 NEUTRAL E1 LINER 32MM D PROSTHESIS HIP PBI ZIMMER BIOMET, INC. N/A 6363084

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention