BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER BIOMET FREEDOM

    MDR report key: 23192872 · Received October 1, 2025

    Report

    Report Number
    0001822565-2025-03630
    Event Type
    Injury
    Date Received
    October 1, 2025
    Date of Event
    September 11, 2025
    Report Date
    November 11, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    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). D10: CAT: 010000980 LOT: R7307574A G7 FREEDOM CONST E1 LNR 32MM B. G2: FOREIGN ¿ AUSTRALIA. H6: SUGGESTED 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.

    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; H4; H6. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED EXPLANTED DEVICES, BIO-DEBRIS PRESENT. THIS CANNOT BE USED TO CONFIRM THE REPORTED EVENT. DEVICES NOT RETURNED, FURTHER ANALYSIS CANNOT BE MADE. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THIS COMPLAINT IS NOT 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY FOUR YEARS POST-IMPLANTATION, THE PATIENT UNDERWENT A LEFT HIP REVISION DUE TO DISLOCATION. THE HEAD AND LINER WERE REVISED. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2105854 ZIMMER BIOMET FREEDOM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. 3009773

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R