BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPT 12/14 SZ 4 COCR 230MM EXT

    MDR report key: 20799567 · Received November 27, 2024

    Report

    Report Number
    0002648920-2024-00365
    Event Type
    Injury
    Date Received
    November 27, 2024
    Date of Event
    November 4, 2024
    Report Date
    February 27, 2025
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JDI
    PMA / PMN Number
    K191735
    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: H6 SUGGESTED COMPONENT CODE: MECHANICAL (G04) - STEM. 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. RADIOGRAPHS WERE PROVIDED AND WERE NOT REVIEWED BY A HEALTH CARE PROFESSIONAL AS USER ERROR WAS DETERMINED DURING FOLLOW UP. THE ROOT CAUSE OF THE REPORTED EVENT IS ATTRIBUTED TO THE USER NOT FOLLOWING INSTRUCTIONS FOR USE IFU 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. THE EVENT IS CONFIRMED AS THE KIWI HIP PROCEDURE WAS USED RATHER THAN SPACERS. 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: (B)(6) ITEM NAME CABLE READY GTR COCR CABLE LOT # 66418000. (B)(6) ITEM NAME CABLE READY GTR COCR CABLE LOT # 66577127. (B)(6) ITEM NAME CABLE READY GTR COCR CABLE LOT # 66418003. (B)(6) ITEM NAME CONSTRAINED HEAD 12/14 TAPER 36 MM DIAMETER +0 MM NECK LENGTH FOR USE WITH FREEDOM CONSTRAINED LINERS LOT # 3171488. (B)(6) ITEM NAME FREEDOM ALL POLY CUP 54MM LOT # 437070. 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
    832106 CPT 12/14 SZ 4 COCR 230MM EXT PROSTHETIC, HIP JDI ZIMMER MANUFACTURING B.V. N/A 64309680

    Patients

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