BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE SHOULDER SYSTEM MINI HUMERAL STEM

    MDR report key: 6787917 · Received August 11, 2017

    Report

    Report Number
    0001825034-2017-06109
    Event Type
    Injury
    Date Received
    August 11, 2017
    Report Date
    October 25, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBF
    PMA / PMN Number
    PK060692
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UDI#: (B)(4). MEDICAL PRODUCTS: GLENOID POST CATALOG#:PT-113950 LOT#:000070, TAPER CATALOG#:118001 LOT#:465220, GLENOID CATALOG#:113952 LOT#:119270, HUMERAL HEAD CATALOG#:113046 LOT#:881530. THE COMPLAINT DEVICE IS NOT EXPECTED FOR RETURN CURRENTLY, AS THE DEVICE REMAINS IMPLANTED, HOWEVER, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-04337, 0001825034-2017-06101, 0001825034-2017-06107, 0001825034-2017-06114.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED EVENT COULD NOT BE CONFIRMED BASED ON LIMITED INFORMATION RECEIVED. NO PRODUCTS WERE RETURNED; THEREFORE, THE VISUAL AND DIMENSION INSPECTION WAS NOT PERFORMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. COMPATIBILITY CHECK IDENTIFIED NO ISSUES. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. 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 · 1

    IT WAS REPORTED THAT THE PATIENT HAS BEEN INDICATED FOR A POSSIBLE SHOULDER ARTHROPLASTY REVISION DUE TO UNKNOWN REASONS. A CUSTOM COMPREHENSIVE VAULT RECONSTRUCTIVE SYSTEM (VRS) GLENOID HAS BEEN REQUESTED. NO FURTHER INFORMATION HAS BEEN PROVIDED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION IS IN PROGRESS, HOWEVER FURTHER INFORMATION IS NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568466 COMPREHENSIVE SHOULDER SYSTEM MINI HUMERAL STEM PROSTHESIS, SHOULDER MBF BIOMET ORTHOPEDICS N/A 375230

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention