BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSA-DIAL/COMP TI STD TAPER

    MDR report key: 10065023 · Received May 18, 2020

    Report

    Report Number
    0001825034-2020-02014
    Event Type
    Injury
    Date Received
    May 18, 2020
    Date of Event
    September 4, 2019
    Report Date
    July 9, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    K080642
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, THE TAPER WAS DETERMINED, TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR. AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, THE TAPER WAS DETERMINED, TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR .AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). PROCODE: PHX. CONCOMITANT MEDICAL PRODUCTS: COMP RVS HMRL TI TRAY 44MM, CAT#: 115340, LOT#: 680760. COMP RVRS SHLDR GLNSP STD 36MM, CAT#: 115310, LOT#: 590020. ARCOM XL 44-36 STD HMRL BRNG, CAT#: XL-115363, LOT#: 370900. COMP RVRS SHDR GLEN BSPLT +HA, CAT#: 115330, LOT#: 172630. COMP PRIMARY STEM 14MM STD, CAT#: 113654, LOT#: 007880. COMP RVS CNTRL SCR 6.5X30MM ST, CAT#: 115382, LOT#: 791300. COMP LOCKING SCREW 4.75X15MM, CAT#: 180500, LOT#: 199570. COMP LOCKING SCREW 4.75X30MM, CAT#: 180503, LOT#: 199610. COMP LOCKING SCREW 4.75X30MM, CAT#: 180503, LOT#: 402230. 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 - 2020 - 02013, 0001825034 - 2020 - 02015, 0001825034 - 2020 - 02016.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL LEFT REVERSE TOTAL SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 9 YEARS DUE TO PAIN AND DYSFUNCTION OF THE SHOULDER. DURING THE REVISION, A FRACTURED HUMERAL TRAY WAS IDENTIFIED WITH SOME INSTABILITY OF THE CUP. THE HUMERAL TRAY, GLENOSPHERE, AND BEARING WERE REPLACED WITHOUT COMPLICATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530930 VERSA-DIAL/COMP TI STD TAPER PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. NI 739220

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10