BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 HI-WALL E1 LINER 36MM F

    MDR report key: 7554277 · Received May 30, 2018

    Report

    Report Number
    0001825034-2018-03405
    Event Type
    Injury
    Date Received
    May 30, 2018
    Date of Event
    July 5, 2018
    Report Date
    April 17, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 010000665, G7 PPS LTD ACET SHELL 56F, 6242109. (B)(6). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INITIAL HIP PROCEDURE, THE LINER DIDN¿T SEAT WITH THE CUP, THE LINER WAS IMPACTED NUMEROUS TIMES, THIS DID NOT CAUSE IT TO SEAT PROPERLY. IT HAD TO BE REMOVED WITH THE LINER EXTRACTION TOOL WHICH DAMAGED THE LINER. THE PROCEDURE WAS COMPLETED WITH A SECOND LINER ON SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398004 G7 HI-WALL E1 LINER 36MM F PROSTHESIS HIP PBI ZIMMER BIOMET, INC. N/A 6250824

    Patients

    Seq Age Sex Outcome Treatment
    1