BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE ARCOMXL STANDARD HUMERAL BEARING

    MDR report key: 8004650 · Received October 25, 2018

    Report

    Report Number
    0001825034-2018-09923
    Event Type
    Injury
    Date Received
    October 25, 2018
    Report Date
    March 27, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    K080642
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED 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 EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 010000589,COMPREHENSIVE MINI BASEPLATE & TAPER ADAPTOR, 926840; 115310,VERSA-DIAL GLENOSPHERE STANDARD, 626240; 115370,COBALT CHROME STANDARD HUMERAL TRAY, 597170; 113631,COMPREHENSIVE HUMERAL STEM¿MINI, 950590. THERAPY DATE - (B)(6) 2016. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-09920, 0001825034-2018-09921, 0001825034-2018-09922, 0001825034-2018-09924. PATIENT NOT YET REVISED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT PATIENT HAD INITIAL COMPREHENSIVE REVERSE SHOULDER ARTHROPLASTY. FOUR (4) MONTHS POST INITIAL SURGERY, PATIENT HAD ABSCESS ON INCISION SITE. SIX (6) MONTHS LATER, IRRIGATION AND DEBRIDEMENT WAS PERFORMED WHERE ABSCESS WAS OPENED AND CLEANED AND CULTURES WERE TAKEN. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845142 COMPREHENSIVE REVERSE ARCOMXL STANDARD HUMERAL BEARING PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A 073050

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention