BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-MOD HUM HEAD 54DIAX22MM

    MDR report key: 6900429 · Received September 28, 2017

    Report

    Report Number
    0001825034-2017-07494
    Event Type
    Injury
    Date Received
    September 28, 2017
    Date of Event
    August 14, 2008
    Report Date
    December 28, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    PK992119
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO NOT BE REPORTABLE. THERE ARE NO ALLEGATIONS OF FAILURE OF THE DEVICE AND THE INITIAL REPORT WAS SUBMITTED IN ERROR.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. CONCOMITANT PRODUCT: 113770, BIO MODULAR HUMERAL HEAD, 789660. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2017 - 07492.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT SHOULDER HEMIARTHROPLASTY PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO PAIN AND PERSISTENT DYSFUNCTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680481 BIO-MOD HUM HEAD 54DIAX22MM PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A 918320

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R