BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SM HYBRID GLENOID BASE 4MM

    MDR report key: 15258389 · Received August 19, 2022

    Report

    Report Number
    0001825034-2022-01884
    Event Type
    Injury
    Date Received
    August 19, 2022
    Date of Event
    May 3, 2022
    Report Date
    August 19, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBF
    UDI-DI
    00880304462625
    PMA / PMN Number
    K193038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2022-00842-2. MEDICAL PRODUCTS: ITEM#: 113044, VERSA-DIAL 46X21X50 HUM HEAD; LOT#: J7089153. ITEM#: PT-113950, PT HYBRID GLEN POST REGENEREX; LOT#: 964350. ITEM#: 113631, COMP PRIMARY STEM 11MM MINI; LOT#: 65025650. ITEM#: 118001, VERSA-DIAL/COMP TI STD TAPER, LOT#: 465650. 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: SIGNIFICANT FINDINGS INCLUDE JOINT INSTABILITY DUE TO THE APPARENT OSTEOLYSIS AND SUSPECTED GLENOID IMPLANT LOOSENING. 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

    IT WAS REPORTED THAT THE PATIENT WAS BEING CONSIDERED FOR A REVISION SURGERY DUE TO FAILURE OF THEIR SUBSCAPULARIS THAT LEAD TO THE PATIENT'S GLENO HUMERAL JOINT UNSTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1994219 SM HYBRID GLENOID BASE 4MM PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED/EXTREMITIES MBF ZIMMER BIOMET, INC. 113952 992960 00880304462625

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Hospitalization| R