BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CR 40MM GLENOSPHERE +3MM COCR

    MDR report key: 11831644 · Received May 17, 2021

    Report

    Report Number
    0001822565-2021-01344
    Event Type
    Injury
    Date Received
    May 17, 2021
    Date of Event
    April 21, 2021
    Report Date
    September 8, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    K181611
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; D4; G3; G6; H1; H2; H3; H6. A 40MM GLENOSPHERE (LOT 64473989) WAS RETURNED FOR EVALUATION. AS RETURNED, WITNESS MARKS AND DAMAGE ARE SEEN ON THE TAPER. THE BUFFED SURFACE EXHIBITS DAMAGE / SCUFFS. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE ISSUE. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT 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). CONCOMITANT MEDICAL PRODUCTS: ITEM#: 118001, VERSA-DIAL/COMP TI STD TAPER; LOT#: 984380; ITEM#: 110031422, CR PROLONG 40MM BRNG +3; LOT#: 64489343; ITEM#: 110031405, MINI TRAY STD COCR +6 OFFSET; LOT#: 64675203; DEVICE EVALUATED BY MFR: PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT AN INITIAL RIGHT SHOULDER PROCEDURE ON AN UNKNOWN DATE. THE PATIENT HAD A REVISION OF THE RIGHT SHOULDER PROCEDURE DUE TO DISASSOCIATION OF COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726904 CR 40MM GLENOSPHERE +3MM COCR SHOULDER PROSTHESIS/EXTREMITIES KWS ZIMMER BIOMET, INC. N/A 64473989

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R