BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSA-DIAL 46X21X50 HUMERAL HEAD

    MDR report key: 6011899 · Received October 7, 2016

    Report

    Report Number
    0001825034-2016-04028
    Event Type
    Injury
    Date Received
    October 7, 2016
    Report Date
    August 31, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBF
    PMA / PMN Number
    PK060716
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THE LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THIS REPORT IS NUMBER 3 OF 3 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2016-03684 / 04019 / 04028).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. (B)(4). MEDICAL PRODUCT- NANO HUMERAL COMPONENT CATALOG#: US-115736 LOT#: 562100, TAPER CATALOG#: 118001 LOT#: 140640, GLENOID CATALOG#: 113952 LOT#: 340890, GLENOID POST CATALOG#: PT-113950 LOT#: 090910. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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

    PATIENT REPORTED IMPINGEMENT OF RIGHT SHOULDER PROSTHESIS AT THE 3 MONTH POST-OP CHECK-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662918 VERSA-DIAL 46X21X50 HUMERAL HEAD PROSTHESIS, SHOULDER MBF BIOMET ORTHOPEDICS N/A 206230

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention