BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSA-DIAL 42X18X46 HUM HEAD

    MDR report key: 6958601 · Received October 18, 2017

    Report

    Report Number
    0001825034-2017-09132
    Event Type
    Injury
    Date Received
    October 18, 2017
    Date of Event
    June 10, 2015
    Report Date
    October 18, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    PK060716
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: ITEM# PT-113950; LOT#470030 - PT HYBRID GLEN POST REGENEREX ITEM#118001; LOT#920210 - VERSA-DIAL/COMP TI STD TAPER ITEM#113952; LOT#531570 - SM HYBRID GLENOID BASE 4MM. THE PRODUCT WAS NOT AVAILABLE FOR RETURN. ROOT CAUSE ATTRIBUTED TO PATIENT FALL. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED ISSUES FOR THIS ITEM. REVIEW OF DEVICE HISTORY RECORDS FOUND THESE UNITS WERE RELEASED TO DISTRIBUTION WITH NO DEVIATIONS OR ANOMALIES. COMPLETION OF THE INVESTIGATION RELAYED TO SALES REP VIA E-MAIL. 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. THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL SHOULDER ARTHROPLASTY ON (B)(6). SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) DUE TO ROTATOR CUFF RUPTURE CAUSED BY PATIENT FALL. THE HUMERAL HEAD WITH ADAPTOR AND GLENOID BASE WITH REGENEREX POST WERE REMOVED AND REPLACED WITH COMPREHENSIVE REVERSE COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738972 VERSA-DIAL 42X18X46 HUM HEAD PROSTHESIS - SHOULDER KWS ZIMMER BIOMET, INC. NI 355530

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention