BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEDOM ALL POLY CUP 54MM

    MDR report key: 20820276 · Received December 2, 2024

    Report

    Report Number
    0001825034-2024-02800
    Event Type
    Injury
    Date Received
    December 2, 2024
    Date of Event
    November 4, 2024
    Report Date
    January 16, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWZ
    UDI-DI
    00880304203600
    PMA / PMN Number
    K030047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: B4, G3, G6, H2, H6, H8, H11. 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 RELATED TO THE REPORTED EVENT. MEDICAL RECORDS WERE NOT PROVIDED. THE ROOT CAUSE OF THE REPORTED EVENT IS ATTRIBUTED TO THE USER NOT FOLLOWING INSTRUCTIONS FOR USE INDICATES UNDER THE CONTRADICTIONS SECTION THAT THE DEVICE SHOULD NOT BE USED IF THERE ARE ANY ACTIVE OR SUSPECTED INFECTION IN OR ABOUT THE HIP. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 00-2232-004-18 ITEM NAME CABLE READY GTR COCR CABLE LOT # 66418000 00-2232-004-18 ITEM NAME CABLE READY GTR COCR CABLE LOT # 66577127 00-2232-004-18 ITEM NAME CABLE READY GTR COCR CABLE LOT # 66418003 802403603 ITEM NAME CONSTRAINED HEAD 12/14 TAPER 36 MM DIAMETER +0 MM NECK LENGTH FOR USE WITH FREEDOM CONSTRAINED LINERS LOT # 3171488 00-8114-004-23 ITEM NAME CPT 12/14 SZ 4 COCR 230MM EXT LOT # 64309680. G2: FOREIGN: AUSTRALIA. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT¿S LOCATION IS NOT KNOWN; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED

    Description of Event or Problem · 0

    THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SECOND STAGE REVISION PROCEDURE AFTER A SUCCESSFUL FIRST STAGE DUE TO UNKNOWN REASONS. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97968 FREEDOM ALL POLY CUP 54MM PROSTHETIC, HIP KWZ ZIMMER BIOMET, INC. N/A 437070 00880304203600

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Required Intervention| H PLEASE SEE H11