BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVRS SHLDR GLNSP STD 36MM

    MDR report key: 6904768 · Received September 29, 2017

    Report

    Report Number
    0001825034-2017-07589
    Event Type
    Injury
    Date Received
    September 29, 2017
    Date of Event
    August 25, 2017
    Report Date
    December 28, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PAO
    PMA / PMN Number
    PK080642
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. CONCOMITANT MEDICAL PRODUCTS: 118001, VERSA-DIAL/COMP TI STD TAPER, 297720. 115330, BIOMOD/COMP REV BASE STD, 436740. 118001, VERSA-DIAL/COMP TI STD TAPER, 297700. 11-113706, BIO-MOD ST.10X115 W/ALIGN HOLE, 936090. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-07590, 0001825034-2017-07591, 0001825034-2017-07592.

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THAT THIS DEVICE WAS NOT INVOLVED IN THE EVENT. THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT SHOULDER REVISION APPROXIMATELY SIX YEARS POST-IMPLANTATION DUE TO PAIN, DYSFUNCTION, ASEPTIC LOOSENING, ELEVATED METAL ION LEVELS, AND ADVERSE LOCAL TISSUE REACTION. DURING THE REVISION, THE GLENOSPHERE AND BASEPLATE WERE FOUND TO BE LOOSE. EXTENSIVE WEAR ON TRUNNION WAS NOTED, WHICH IS SUSPECTED TO BE THE SOURCE OF THE METALLOSIS AND METAL ION ELEVATION. ALL COMPONENTS WERE REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684987 COMP RVRS SHLDR GLNSP STD 36MM PROSTHESIS, SHOULDER PAO ZIMMER BIOMET, INC. N/A 593670

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R