BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVS CNTRL 6.5X30MM ST/RST

    MDR report key: 8270187 · Received January 23, 2019

    Report

    Report Number
    0001825034-2019-00216
    Event Type
    Injury
    Date Received
    January 23, 2019
    Date of Event
    December 29, 2018
    Report Date
    March 12, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    K132239
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THAT THE PRODUCT WAS NOT RE PORTABLE AS IT WAS NOT EXPLANTED AND THE INITIAL REPORT WAS SUBMITTED IN ERROR AND NEEDS TO BE VOIDED.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THAT THE PRODUCT WAS NOT RE PORTABLE AS IT WAS NOT EXPLANTED AND THE INITIAL REPORT WAS SUBMITTED IN ERROR AND NEEDS TO BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 115320 COMP RVRS SHLDR GLNSP STD 41MM 982880, 110032410 COMP AUG MINI BSPLT W TPR SM 64027393, 115370 COMP RVS TRAY CO 44MM 430240, UNKNOWN HUMERAL STEM. FOREIGN- (B)(6). THE COMPLAINT IS UNDER INVESTIGATION. ONCE THE INVESTIGATION IS COMPLETED A FOLLOW UP REPORT WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2019 - 00213, 0001825034 - 2019 - 00214, 0001825034 - 2019 - 00215.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL REVERSE SHOULDER ARTHROPLASTY AND UNDERWENT A REVISION DUE TO HEMATOMA APPROXIMATELY ONE MONTH POST IMPLANTATION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64490 COMP RVS CNTRL 6.5X30MM ST/RST PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A 512120

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R