BEUDAMED
    FDA Adverse Event Injury Summary report: N

    36MM COCR MOD HD STD

    MDR report key: 16601052 · Received March 23, 2023

    Report

    Report Number
    0001825034-2023-00641
    Event Type
    Injury
    Date Received
    March 23, 2023
    Date of Event
    February 28, 2023
    Report Date
    April 18, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    UDI-DI
    00887858307959
    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. UPDATED: 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. TWO IMAGES ASSESS AND NOT SUBMITTED TO MMI AS THE EVENT REPORTS A SINGLE INCIDENT OF DISLOCATION WHICH IS NOT CAPTURED WITHIN THE IMAGES. OPERATIVE NOTES FROM THE REVISION WERE NOT PROVIDED. REVIEW OF THE MEDICAL NOTES FROM THE INITIAL OPERATION FOUND NO A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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). CONCOMITANT MEDICAL PRODUCTS:: 010000702, G7 BONEMASTER LTD ACET SHL 50D, LOT NUMBER: 7123585. 01000085,6 G7 NEUTRAL E1 LINER 36MM D, LOT NUMBER: 7244646. REPORT SOURCE: FOREIGN: AUSTRALIA. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2023 - 00639. 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, AS SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. DEVICE LOCATION IS UNKNOWN.

    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 PT UNDERWENT A REVISION PROCEDURE 3 MONTHS 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
    1809183 36MM COCR MOD HD STD PROSTHETIC, HIP JDI ZIMMER BIOMET, INC. N/A 064200 00887858307959

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Unknown Hospitalization| R