BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 NEUTRAL E1 LINER 36MM E

    MDR report key: 7777529 · Received August 13, 2018

    Report

    Report Number
    0001825034-2018-04501
    Event Type
    Malfunction
    Date Received
    August 13, 2018
    Report Date
    December 27, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK121874
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UDI: (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). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. ADDITIONAL CONCOMITANT MEDICAL PRODUCTS: ITEM NUMBER: 110017103, ITEM NAME: G7 FINNED 3 HOLE SHELL 52E, LOT #: 6112587. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 04502. 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 LINER DID NOT SEAT INTO THE CUP CORRECTLY, WHEN ATTEMPTING TO REMOVE THE LINER BOTH THE CUP AND LINER FELL OUT OF PATIENT. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618288 G7 NEUTRAL E1 LINER 36MM E PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 6180819

    Patients

    Seq Age Sex Outcome Treatment
    1