BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEDOM CONSTR HD 36MM T1 -6MM

    MDR report key: 19766462 · Received July 17, 2024

    Report

    Report Number
    0001825034-2024-01866
    Event Type
    Injury
    Date Received
    July 17, 2024
    Date of Event
    June 22, 2024
    Report Date
    June 11, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWZ
    UDI-DI
    00880304203433
    PMA / PMN Number
    K030047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 010000985 ITEM NAME G7 FREEDOM CONST E1 LNR 36MM G LOT # 6771739. G2: FOREIGN: CANADA. 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED. UPDATED: H6 SUGGESTED COMPONENT CODE: MECHANICAL (G04) - HEAD. 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. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE COMPLAINT CANNOT BE 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; G3; H2; H3; H6; H10. H6: COMPONENT CODE: MECHANICAL (G04) - HEAD. PRODUCT WAS RETURNED AND EVALUATED. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED THAT THE HEAD WAS RETURNED SEATED IN THE LINER. THE SPHERICAL SURFACE SHOWED SIGNIFICANT SCRATCHES ON ONE SIDE. THE TAPER HOLE AND REST OF THE SPHERICAL SURFACE SHOWED SCRATCHES FROM USE. NO OTHER DAMAGE WAS NOTED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. THE ROOT CAUSE REMAINS UNCHANGED; A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE COMPLAINT REMAINS UNCONFIRMED. 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 THE PATIENT UNDERWENT A REVISION PROCEDURE 9 MONTHS AND 12 DAYS POST IMPLANTATION DUE TO A DISLOCATION. LOOKING AT THE LINER UPON REMOVAL IT WAS EVIDENT THERE WAS SOME DAMAGE THAT LOOKED TO BE FROM LEVERING. SURGEON WAS UNCERTAIN IF IT WAS A DEFICIENCY OR IF MAXIMUM LEVERAGE FORCE WAS ACHIEVED THAT ALLOWED THIS LINER TO BE DAMAGED/ FOR THE HIP TO DISLOCATE AND BE REDUCED. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2142815 FREEDOM CONSTR HD 36MM T1 -6MM PROSTHETIC, HIP KWZ ZIMMER BIOMET, INC. N/A 739420 00880304203433

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H PLEASE SEE H11.