BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SM HYBRID GLENOID BASE 4MM

    MDR report key: 12843606 · Received November 19, 2021

    Report

    Report Number
    0001825034-2021-03171
    Event Type
    Injury
    Date Received
    November 19, 2021
    Report Date
    December 30, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBF
    PMA / PMN Number
    K193038
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D10: 113631 COMP PRIMARY STEM 11MM MINI 931610. 113044 VERSA-DIAL 46X21X50 HUM HEAD 329840. PT-113950 PT HYBRID GLEN POST REGENEREX 530430. 118001 VERSA-DIAL/COMP TI STD TAPER 861240. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM #: UNKNOWN, UNKNOWN HUMERAL TRAY, LOT #: UNKNOWN. ITEM #: UNKNOWN, UNKNOWN HUMERAL STEM, LOT #: UNKNOWN. ITEM #: UNKNOWN, UNKNOWN HUMERAL BEARING, LOT #: UNKNOWN. ITEM #: UNKNOWN, UNKNOWN GLENOSPHERE, LOT #: UNKNOWN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: TWO VIEWS OF THE LEFT SHOULDER DEMONSTRATE A LEFT TOTAL SHOULDER ARTHROPLASTY WITH BONY REMODELING OF THE GLENOID AS WELL AS SIGNIFICANT RADIOLUCENCY AT THE BONE CEMENT INTERFACE OF THE GLENOID CONSISTENT WITH LOOSENING. POSSIBLE FRACTURE INVOLVING THE INFERIOR GLENOID ON THE AP FILM. OSTEOPENIA. MILD AC JOINT DEGENERATIVE CHANGE. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2021-03515.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL ANATOMICAL LEFT SHOULDER ARTHROPLASTY. THE PATIENT PLANS TO BE REVISED EIGHT YEARS POST IMPLANTATION TO A REVERSE TSA DUE TO LOOSENING OF THE GLENOID BASEPLATE COMPONENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH PMI THAT THE PATIENT UNDERWENT AN INITIAL LEFT SHOULDER ARTHROPLASTY ON AN UNKNOWN DATE. THE PATIENT PLANS TO BE REVISED DUE TO UNKNOWN REASON. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1741305 SM HYBRID GLENOID BASE 4MM PROSTHESIS, SHOULDER MBF ZIMMER BIOMET, INC. N/A NI
    1741306 SM HYBRID GLENOID BASE 4MM PROSTHESIS, SHOULDER MBF ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other SEE H10