BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVENIR COMPLETE

    MDR report key: 22778909 · Received August 11, 2025

    Report

    Report Number
    0001822565-2025-02879
    Event Type
    Injury
    Date Received
    August 11, 2025
    Date of Event
    July 16, 2025
    Report Date
    September 17, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    UDI-DI
    00889024509160
    PMA / PMN Number
    K182048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: CAT: 802203205 LOT: 3051621 FEMORAL HEAD G2: FOREIGN ¿ AUSTRALIA H6: MECHANICAL (G04) - STEM. THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS ITS LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: A1; A2; A3; G3; H2. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: D4; G3; H2; H3; H4; H6. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE OF THE REPORTED FALL CANNOT BE DETERMINED; HOWEVER, IT WAS NOTED THERE WAS A PATIENT NON-COMPLIANCE BUT WHAT THE NON-COMPLIANCE WAS IS UNKNOWN AT THIS TIME. UNABLE TO CONFIRM COMPLAINT. 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

    IT WAS REPORTED THAT APPROXIMATELY ONE-WEEK POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO A FALL AND PERI-PROSTHETIC FRACTURE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2171597 AVENIR COMPLETE PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. 3233537 00889024509160

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Hospitalization| R