BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK COMPREHENSIVE REVERSE HUMERAL STEM

    MDR report key: 11265956 · Received February 2, 2021

    Report

    Report Number
    0001825034-2021-00276
    Event Type
    Injury
    Date Received
    February 2, 2021
    Report Date
    March 29, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NEITHER WERE 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 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.

    Additional Manufacturer Narrative · 1

    (B)(4). RANGARAJAN, RAJESH MD, BLOUT, COLLIN K. BS, PATEL, VIKAS V. MD. (2020). EARLY RESULTS OF REVERSE TOTAL SHOULDER ARTHROPLASTY USING A PATIENT-MATCHED GLENOID IMPLANT FOR SEVERE GLENOID BONE DEFICIENCY. JOURNAL OF SHOULDER AND ELBOW SURGERY, 29, 139-148. HTTPS://DOI.ORG/10.1016/J.JSE.2020.04.024. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE RETRIEVED FROM THE JOURNAL OF SHOULDER AND ELBOW SURGERY (2020), WHICH STUDIED PATIENTS WHO UNDERWENT RTSA USING VRS, THAT ONE PATIENT UNDERWENT 3 PROCEDURES WITHIN 2 MONTHS OF REVISION RTSA USING THE VRS. SUBSEQUENTLY, THE HUMERAL COMPONENT WAS REVISED IN THE FIRST TWO PROCEDURES DUE TO RECURRENT INSTABILITY. THE PATIENT SHOWED CONTINUED STABILITY AFTER THE LAST PROCEDURE (REMOVAL OF HEMATOMA) >2 YEARS AGO. 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
    164424 UNK COMPREHENSIVE REVERSE HUMERAL STEM PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R