BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSA-DIAL 38X19X39 HUMERAL HEAD

    MDR report key: 7779344 · Received August 13, 2018

    Report

    Report Number
    0001825034-2018-05122
    Event Type
    Injury
    Date Received
    August 13, 2018
    Date of Event
    June 28, 2018
    Report Date
    February 1, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBF
    PMA / PMN Number
    PK060716
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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. 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 · 0

    NO FURTHER INFORMATION AVAILABLE AT THE TIME OF THIS REPORTING.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG # NI, UNKNOWN COMPREHENSIVE HUMERAL STEM, LOT # NI; CATALOG # 113952, SM HYBRID GLENOID BASE 4MM, LOT # 870500; CATALOG # PT-113950, PT HYBRID GLEN POST REGENEREX, LOT # 436900; CATALOG # 118001, VERSA-DIAL/(B)(6), LOT # 639410. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-05121, 0001825034-2018-05122. PRODUCT HAS BEEN DISCARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO INSTABILITY AND REPORTS OF DISLOCATION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617308 VERSA-DIAL 38X19X39 HUMERAL HEAD PROSTHESIS, SHOULDER MBF ZIMMER BIOMET, INC. N/A 073390

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| R