BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYBRID(TM) GLENOID BASE

    MDR report key: 20407732 · Received October 9, 2024

    Report

    Report Number
    0001825034-2024-02382
    Event Type
    Injury
    Date Received
    October 9, 2024
    Date of Event
    September 19, 2024
    Report Date
    October 11, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBF
    PMA / PMN Number
    K193038
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; D2; G1; G3; G6; H1; H2; H3; H6; H10. THE RETURNED PRODUCTS CONFIRM THE REPORTED WEAR; HOWEVER, THE LOOSENING OF THE DEVICES CANNOT BE CONFIRMED. VISUAL EXAMINATION OF THE RETURNED PRODUCT/PROVIDED PICTURES IDENTIFIED THE GLENOID RETURNED AS DAMAGED TO BOTH THE WORKING AND NON-WORKING SURFACES. THERE ARE DEEP SCRATCHES AND GOUGES ON THE WORKING SURFACE. THE POST IS NO LONGER LOCATED IN THE GLENOID AND WAS RETURNED SEPARATELY. THE POST ALSO SHOWS SIGNS OF DAMAGE WITH NICKS AND GOUGES AND PART OF THE POST HAS FRACTURED OFF AND NOT RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. 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 REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. ASSOCIATED REPORTS ARE AVAILABLE FOR THE APPLICABLE CONCOMITANT PRODUCTS BELOW IN THE D10 NARRATIVE. D10: CONCOMITANT MEDICAL PRODUCTS, PART (LOT): - PT-113950 (B)(6). ASSOCIATED PRODUCT INFORMATION: - 113630 (B)(6) - 113032 (B)(6) - 118001 (B)(6). THE 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. IF ANY FURTHER INFORMATION IS FOUND THAT 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 IS AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY TWELVE (12) YEARS AFTER A LEFT ANATOMIC SHOULDER ARTHROPLASTY PROCEDURE, THE PATIENT UNDERWENT A REVISION CONVERSION TO HEMIARTHROPLASTY DUE TO GLENOID LOOSENING. THE HUMERAL COMPONENTS WERE REMOVED TO GAIN ACCESS TO THE LOOSENED AND WORN GLENOID BASE AND POST. THE BASE AND POST WERE REMOVED AND THE HUMERAL COMPONENTS WERE REPLACED SUCCESSFULLY WITHOUT ANY REPORTED ADVERSE OUTCOMES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729710 HYBRID(TM) GLENOID BASE PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED MBF ZIMMER BIOMET, INC. NI 615690

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R H11