BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 VIT E NEUTRAL LNR 36MM F

    MDR report key: 16914859 · Received May 11, 2023

    Report

    Report Number
    0001822565-2023-01287
    Event Type
    Injury
    Date Received
    May 11, 2023
    Date of Event
    April 15, 2023
    Report Date
    July 14, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024519916
    PMA / PMN Number
    K190660
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. UNABLE TO CONFIRM COMPLAINT AS NO PRODUCT WAS RETURNED OR IMAGES PROVIDED. MEDICAL RECORDS WERE NOT PROVIDED. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). D6A: APPROXIMATELY (B)(6) 2022. D10: 650-1065 CER OPTION TYPE 1 TPR SLEVE -3 LOT NUMBER 3130574. 650-1057 CER BIOLOXD OPTION HD 36MM LOT NUMBER 3102327. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. H3 OTHER TEXT : DEVICE IN PROCESS TO RETURN.

    Description of Event or Problem · 0

    THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 6 MONTHS POST IMPLANTATION DUE TO A FALL. THE PATIENT WAS NO LONGER STABLE DUE TO TISSUE DAMAGE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500147 G7 VIT E NEUTRAL LNR 36MM F PROSTHETIC, HIP LPH ZIMMER BIOMET, INC. N/A 65596487 00889024519916

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention| H PLEASE SEE H10.