BEUDAMED
    FDA Adverse Event Injury Summary report: N

    36MM COCR MOD HD +9MM

    MDR report key: 12906198 · Received November 30, 2021

    Report

    Report Number
    0001825034-2021-03235
    Event Type
    Injury
    Date Received
    November 30, 2021
    Date of Event
    November 9, 2021
    Report Date
    January 10, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    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. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO 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). REPORT SOURCE: (B)(6). CONCOMITANT MEDICAL PRODUCTS: CATALOG NUMBER:11-363665 LOT NUMBER:318180 BRAND NAME: COCR MOD HEAD. CATALOG NUMBER: 010000937, LOT NUMBER:6694891, BRAND NAME: G7 LINER. CATALOG NUMBER: 51-114180, LOT NUMBER: 6489546, BRAND NAME: TAPERLOC STEM. CATALOG NUMBER: 110010248, LOT NUMBER: 6955794, BRAND NAME: G7 SHELL. MULTIPLE REPORTS WERE SUBMITTED ALONG WITH THIS REPORT: 0001825034-2021-03236. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. DEVICE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION APPROXIMATELY 3 MONTHS POST IMPLANTATION. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1802202 36MM COCR MOD HD +9MM PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 318180

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R