BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SM HYBRID GLENOID BASE 4MM

    MDR report key: 18866428 · Received March 8, 2024

    Report

    Report Number
    0001825034-2024-00523
    Event Type
    Injury
    Date Received
    March 8, 2024
    Date of Event
    November 25, 2022
    Report Date
    March 8, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBF
    UDI-DI
    00880304462625
    PMA / PMN Number
    K193038
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: ANATOMICAL SHOULDER DOMELOCK, DOME, CENTRIC CAT: 0104227005 LOT: 2975075. ANATOMICAL SHOULDER DOMELOCK, HUMERAL HEAD CAT: 0104212465 LOT: 2902802. ANATOMICAL SHOULDER HUMERAL STEM, UNCEMENTED CAT: 0104201123 LOT: 2979183. G2: FOREIGN: BELGIUM. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. RECORDS FROM THE STUDY WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: ROTATOR CUFF TEAR WITH RUPTURE/DISINSERTION OF THE CRANIAL FIBERS OF THE SUBSCAPULARIS AND EXTENSIVE INTERSTITIAL CLEAVAGE TEAR OF THE SUPRASPINATUS NOTED. PATIENT UNDERWENT OPEN ROTATOR CUFF REPAIR. VISITS NOTED NO PAIN AND NO SIGNIFICANT FINDINGS ON XRAYS. THE PATIENT UNDERWENT REVISION TO RIGHT REVERSE SHOULDER ARTHROPLASTY DUE TO INSTABILITY. THE REPORTED EVENT IS NOT CONFIRMED. 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. H3 OTHER TEXT : PRODUCT NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED UNDERWENT A REVISION PROCEDURE TO A REVERSE TOTAL SHOULDER FOR INSTABILITY AND TWO EVENTS OF LUXATION APPROXIMATELY TWO YEARS POST INITIAL PROCEDURE. ALL COMPONENTS, EXCEPT FOR STEM, WAS REVISED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2170157 SM HYBRID GLENOID BASE 4MM SHOULDER, PROSTHESIS MBF ZIMMER BIOMET, INC. 692830 00880304462625

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Hospitalization| R