BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SHELL

    MDR report key: 7764351 · Received August 8, 2018

    Report

    Report Number
    0001825034-2018-06282
    Event Type
    Injury
    Date Received
    August 8, 2018
    Date of Event
    March 21, 2013
    Report Date
    August 7, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: BIOMET MODULAR COCR TYPE I TAPER, PN UNKNOWN, LN UNKNOWN; ARCOS CON SZ C STD 70MM, 11-301323, 942640; ARCOS 17X190MM SPL TPR DIST, 11-300917, 216380. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE REPORTS: 0001825034-2018-06277, 0001825034-2018-06279, 0001825034-2018-06283. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TREATMENT FOR C-DIFF APPROXIMATELY ONE MONTH POST-IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605214 UNKNOWN SHELL PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other