BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BIOMODULAR GLENOID

    MDR report key: 7175087 · Received January 9, 2018

    Report

    Report Number
    0001825034-2018-00057
    Event Type
    Injury
    Date Received
    January 9, 2018
    Date of Event
    December 5, 2017
    Report Date
    March 28, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL CONCOMITANT MEDICAL PRODUCTS: UNKNOWN BIOMODULAR HEAD; UNKNOWN BIOMODULAR STEM. (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT WAS DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS - UNKNOWN BIOMODULAR STEM, BIO-MOD HUM HEAD # ITEM 113732 LOT 881590. ALTHOUGH THE HUMERAL STEM AND HEAD WERE RETURNED, THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED AS THE GLENOID COMPONENT WAS NOT RETURNED FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED HEAD SHOWED SOME SCRATCHES VISIBLE AND DEEP ENOUGH TO FEEL ON THE HEAD AND THERE WERE SURFACE SCRATCHES ON THE STEM. DEVICE HISTORY RECORD (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 · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL SHOULDER REPLACEMENT ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED TO A REVERSE SHOULDER 25 YEARS LATER AS A RESULT OF GLENOID EROSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18939 UNKNOWN BIOMODULAR GLENOID PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R