BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER BIOMET FREEDOM HEAD

    MDR report key: 20015152 · Received August 21, 2024

    Report

    Report Number
    0001822565-2024-02679
    Event Type
    Injury
    Date Received
    August 21, 2024
    Date of Event
    July 25, 2024
    Report Date
    November 11, 2024
    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 THE FOLLOWING SECTIONS WERE CORRECTED: D1 H6: PROPOSED 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 RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW. REVIEW OF THE AVAILABLE INFORMATION IDENTIFIED THE FOLLOWING: THE PATIENT HAD AN INITIAL LEFT THA WITH A HISTORY OF DISLOCATIONS AND A REVISION. THE PATIENT UNDERWENT A SECOND REVISION WHERE THE HEAD AND LINER WERE REVISED. THE POST-OP X-RAYS WOUND NOT CAPTURE THE EVENT OF DISLOCATION. THE CT SLICE IS OF THE PELVIS AND DOES NOT CAPTURE THE DEVICE AND THE OTHER TWO CT SINGLE IMAGES ARE OF 3D RENDERINGS AND ARE NOT DIAGNOSTIC FOR RADIOLOGIST TO REVIEW. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THIS COMPLAINT CANNOT BE CONFIRMED. MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW. 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#6742486 G7 FREEDOM CONST E1 LNR 36MM E. G2: FOREIGN ¿ AUSTRALIA. THE 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.

    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 TWO MONTHS 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1117737 ZIMMER BIOMET FREEDOM HEAD PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 3185694 00889024499089

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R SEE H11 NARRATIVE.