BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOM XL 44-36 RTNV+3 HUMERAL BEARING

    MDR report key: 7779314 · Received August 13, 2018

    Report

    Report Number
    0001825034-2018-05032
    Event Type
    Injury
    Date Received
    August 13, 2018
    Date of Event
    July 31, 2014
    Report Date
    January 8, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    PK080642
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS DETERMINED THIS DEVICE DID NOT CONTRIBUTE TO THE EVENT. PLEASE VOID THIS SUBMISSION.

    Description of Event or Problem · 0

    IT WAS DETERMINED THIS DEVICE DID NOT CONTRIBUTE TO THE EVENT. PLEASE VOID THIS SUBMISSION.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: CSR HUMERAL TRAY ¿ CAT. NO. 115340, LOT NO. 492370; VERSA SHOULDER SYSTEM COMPREHENSIVE SHOULDER ADAPTER ¿ CAT. NO. 118001, LOT NO. 201410; CSR SHOULDER STEM ¿ CAT. NO. 113648, LOT NO. 104520; CSR GLENOSPHERE ¿ CAT. NO. 115310, LOT NO. 609790; CSR GLENOSPHERE BASEPLATE ¿ CAT. NO. 115330, LOT NO. 550050; FIXED LOCKING SCREW ¿ CAT. NO. 180501, LOT NO. 468580. 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. PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT RIGHT TOTAL REVERSE SHOULDER ARTHROPLASTY. SUBSEQUENTLY, THE PATIENTS GLENOSPHERE DISASSOCIATED. THE PATIENT EXPERIENCED DISLOCATION OF THE SHOULDER AS WELL AS POLY WEAR. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620120 ARCOM XL 44-36 RTNV+3 HUMERAL BEARING PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A 635710

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R