BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE VERSA-DIAL HUMERAL HEAD

    MDR report key: 7548826 · Received May 29, 2018

    Report

    Report Number
    0001825034-2018-03597
    Event Type
    Injury
    Date Received
    May 29, 2018
    Report Date
    May 31, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBF
    PMA / PMN Number
    PK060716
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, SINCE THE PATIENT IS NOT YET REVISED. CONCOMITANT MEDICAL PRODUCTS: 113628, COMPREHENSIVE HUMERAL STEM MINI 83 MM, 794550. THE 113952, MODULAR HYBRID GLENOID BASE, 747320. THE 118001, COMPREHENSIVE STANDARD TAPER ADAPTOR, 357470.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO 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 · 1

    IT WAS REPORTED THAT PATIENT HAD INITIAL ANATOMIC SHOULDER ARTHROPLASTY. PATIENT IS BEING CONSIDERED FOR A REVISION SURGERY DUE TO A SUBSCAPULARIS FAILURE. IT IS UNSURE IF THE SUBSCAPULARIS FAILURE IS IMPLANT RELATED OR PATIENT RELATED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391675 COMPREHENSIVE VERSA-DIAL HUMERAL HEAD PROSTHESIS, SHOULDER MBF ZIMMER BIOMET, INC. N/A 488380

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention