BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVSR SHLDR GLNSP +3 41MM

    MDR report key: 8503478 · Received April 11, 2019

    Report

    Report Number
    0001825034-2019-01637
    Event Type
    Injury
    Date Received
    April 11, 2019
    Date of Event
    March 26, 2019
    Report Date
    September 19, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    K080642
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. REVIEW OF THE MEDICAL RECORDS IDENTIFIED THAT WHEN THE PATIENT UNDERWENT A REVISION, DISASSOCIATION WAS FOUND. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES 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.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: 118001, TAPER, LOT 808490, XL-115367, HUMERAL BEARING, LOT 700020, 115370, TRAY, LOT 874190. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2019 - 01638.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 9 MONTHS POST IMPLANTATION, THE PATIENT WAS REVISED DUE TO DISASSOCIATION BETWEEN THE GLENOSPHERE AND TAPER ADAPTOR. REPORTEDLY, THE DISASSOCIATION OCCURRED AFTER A FALL. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295613 COMP RVSR SHLDR GLNSP +3 41MM PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A 350070

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R