BEUDAMED
    FDA Adverse Event Injury Summary report: N

    36MM COCR MOD HD +3MM

    MDR report key: 17921810 · Received October 12, 2023

    Report

    Report Number
    0001825034-2023-02358
    Event Type
    Injury
    Date Received
    October 12, 2023
    Date of Event
    September 15, 2023
    Report Date
    December 20, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    UDI-DI
    00880304210530
    PMA / PMN Number
    K032396
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    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. 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. THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO OFF-LABEL USAGE AS ZIMMER BIOMET PRODUCTS WERE USED IN CONJUNCTION WITH A COMPETITOR DEVICE. ZIMMER BIOMET HAS NOT CONFIRMED THE COMPATIBILITY OF THE REPORTED COMBINATION OF DEVICES, AND THESE WOULD BE CONSIDERED OFF-LABEL USAGES. A SUMMARY OF THE INVESTIGATION WAS SENT TO THE COMPLAINANT CONVEYING PROPER SURGICAL TECHNIQUE AND USE OF THE DEVICE. 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: UNKNOWN LINER, 11-301323. ITEM NAME: ARCOS CON SZ C STD 70MM. LOT #: 111160 11-300920. ITEM NAME: ARCOS 20X190MM SPL TPR DIST. LOT #: 941940. G2: FOREIGN: AUSTRALIA. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS 0001825034 - 2023 - 02359 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. H3 OTHER TEXT : DEVICE LOCATION IS UNKNOWN.

    Description of Event or Problem · 0

    NO FURTHER INFORMATION AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE ONE MONTH POST IMPLANTATION DUE TO DISLOCATION. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1415158 36MM COCR MOD HD +3MM PROSTHETIC, HIP JDI ZIMMER BIOMET, INC. N/A 686470 00880304210530

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention| H PLEASE SEE H10