BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 FREEDOM CONST E1 LNR 36MM G

    MDR report key: 18345481 · Received December 18, 2023

    Report

    Report Number
    0001825034-2023-03010
    Event Type
    Injury
    Date Received
    December 18, 2023
    Date of Event
    November 23, 2023
    Report Date
    March 14, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PBI
    UDI-DI
    00880304989092
    PMA / PMN Number
    K121874
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 802403603 CONSTRAINED HEAD 12/14 TAPER 36 MM DIAMETER +0 MM NECK LENGTH FOR USE WITH FREEDOM CONSTRAINED LINERS 3041611. G2: FOREIGN: AUSTRALIA. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. UNABLE TO CONFIRM COMPLAINT AS NO PRODUCT WAS RETURNED OR MEDICAL RECORDS WERE PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY 7 MONTHS POST IMPLANTATION, THE PATIENT UNDERWENT A REVISION DUE TO DISLOCATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920775 G7 FREEDOM CONST E1 LNR 36MM G PROTHESIS, HIPS PBI ZIMMER BIOMET, INC. N/A 6771746 00880304989092

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Hospitalization| R SEE H10 NARRATIVE.