BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSA-DIAL 42X18X46 HUMERAL HEAD

    MDR report key: 7322196 · Received March 7, 2018

    Report

    Report Number
    0001825034-2018-01720
    Event Type
    Injury
    Date Received
    March 7, 2018
    Date of Event
    April 12, 2011
    Report Date
    April 10, 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
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM NUMBER / ITEM NAME / LOT NUMBER, PT-113950 / PT HYBRID GLEN POST REGENEREX / 652570, 118001 / VERSA-DIAL/COMP TI STD TAPER / 850050, 113954 / MD HYBRID GLENOID BASE 4MM / 896770. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 01719, 0001825034 - 2018 - 01721, 0001825034 - 2018 - 01722. PRODUCT LOCATION UNKNOWN.

    Additional Manufacturer Narrative · 1

    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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT INITIAL LEFT SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO ROTATOR CUFF FAILURE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164233 VERSA-DIAL 42X18X46 HUMERAL HEAD PROSTHESIS, SHOULDER MBF ZIMMER BIOMET, INC. N/A 378630

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R