BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSA-DIAL 50X21X57 HUM HEAD

    MDR report key: 6919044 · Received October 5, 2017

    Report

    Report Number
    0001825034-2017-07441
    Event Type
    Injury
    Date Received
    October 5, 2017
    Date of Event
    April 22, 2016
    Report Date
    March 12, 2018
    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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP REPORT IS BEING SUBMITTED TO REPORT ADDITIONAL INFORMATION CONCOMITANT MEDICAL PRODUCTS: PART: 113956, NAME: LG GLENOID BASE LOT: 240070; PART: 113654, COMP PRIMARY STEM, LOT: 624050; PART: PT-113950, NAME: PT HYBRID GLEN POST REGENEREX , LOT: 271210; PART: 118001, VERSA-DIAL/COMP TI STD TAPER, LOT: 800720; PART: 113053 , VERSA-DIAL 50X21X57 HUM HEAD, LOT: 605230; PART: 405800, COMP. REV SHLDR 9 IN STEINMANN, LOT: 905780.

    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 REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL SHOULDER REPLACEMENT. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO DISLOCATION. THE PATIENT ALSO EXPERIENCED A SUBSCAPULAR FAIL. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694454 VERSA-DIAL 50X21X57 HUM HEAD PROSTHESIS, SHOULDER MBF ZIMMER BIOMET, INC. N/A 605230

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R