BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER BIOMET FREEDOM

    MDR report key: 22809628 · Received August 14, 2025

    Report

    Report Number
    0001822565-2025-02941
    Event Type
    Injury
    Date Received
    August 14, 2025
    Date of Event
    July 12, 2025
    Report Date
    September 3, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024499089
    PMA / PMN Number
    K183457
    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). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: G3; H2; H3; 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. RADIOGRAPHS WERE PROVIDED. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: LEFT TOTAL HIP ARTHROPLASTY WITH POSTERIOR SUPERIOR DISLOCATION. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. BASED ON THE X-RAY FINDINGS, THE COMPLAINT IS CONFIRMED. 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). D10: CAT: 010000983 LOT: 7648567 G7 FREEDOM CONST E1 LNR 36MM E. G2: FOREIGN ¿ AUSTRALIA. H6: PROPOSED COMPONENT CODE: MECHANICAL (G04) - HEAD. 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.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783003 ZIMMER BIOMET FREEDOM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. 3015189 00889024499089

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R