BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PT HYBRID GLEN POST REGENEREX

    MDR report key: 13120394 · Received December 30, 2021

    Report

    Report Number
    0001825034-2021-03515
    Event Type
    Injury
    Date Received
    December 30, 2021
    Report Date
    December 30, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    K060694
    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). CONCOMITANT MEDICAL PRODUCTS: 113952 SM HYBRID GLENOID BASE 4MM 539890, 113631 COMP PRIMARY STEM 11MM MINI 931610, 113044 VERSA-DIAL 46X21X50 HUM HEAD 329840, 118001 VERSA-DIAL/COMP TI STD TAPER 861240. 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: 0001825034-2021-03171.

    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. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2017066 PT HYBRID GLEN POST REGENEREX SHOULDER GLENOID FOSSA PROSTHESIS, PREFABRICATED KWS ZIMMER BIOMET, INC. N/A 530430

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other