BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP 4MM HUM FRAC STEM MACRO

    MDR report key: 8535573 · Received April 22, 2019

    Report

    Report Number
    0001825034-2019-01653
    Event Type
    Injury
    Date Received
    April 22, 2019
    Date of Event
    March 26, 2019
    Report Date
    June 5, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWT
    PMA / PMN Number
    K023063
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION RECEIVED: REPORTED EVENT WAS UNABLE TO BE CONFIRMED. DHR REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 113764 BIO-MOD HUM HEAD 44DIAX17MM UNKNOWN, 113575 COMP FX HUM POS SLEEVE 7MM UNKNOWN, 414994 SMALL DIA CEMENT PLUG 10MM UNKNOWN, UNKNOWN STRYKER IMPLEX CEMENT. REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, HOSPITAL POLICY. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2019 - 01654.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDER WENT AN INITIAL SHOULDER HEMIARTHROPLASTY FOR A FRACTURED SHOULDER AND WAS SUBSEQUENTLY REVISED DUE TO PAIN, REDUCED RANGE OF MOTION DUE TO NON UNION, LOOSENING AND TENDON TEAR ONE (1) YEAR SIX (6) MONTHS POST PRIMARY IMPLANTATION. SURGEON NOTED SUPERIOR GLENOID WEAR AND ORIGINAL FRACTURE DID NOT HEAL FROM THE PRIMARY SURGERY. NO ADDITIONAL INFORMATION IS AVAILABLE FROM THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328325 COMP 4MM HUM FRAC STEM MACRO PROSTHESIS, SHOULDER KWT ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R