BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOM XL 44-36 STD HMRL BRNG

    MDR report key: 7830583 · Received August 29, 2018

    Report

    Report Number
    0001825034-2018-08622
    Event Type
    Injury
    Date Received
    August 29, 2018
    Date of Event
    June 12, 2014
    Report Date
    November 29, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    PMA / PMN Number
    PK080642
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (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 ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT CODE: PHX. CONCOMITANT MEDICAL PRODUCTS: CATALOG #: 180558, LOT #: 354080, COMP NLK SCR 3.5HEX 4.75X20 ST; 180553, 585670, COMP LK SCR 3.5HEX 4.75X30 ST; 180554, 705780, COMP LK SCR 3.5HEX 4.75X35 ST; 115370, 766930, COMP RVS TRAY CO 44MM; 010000589, 978220 ,COMP RVRS 25MM BSPLT HA+ADPTR; 115382, 827110, COMP RVS CNTRL SCR 6.5X30MM ST; 115310, 677090, COMP RVRS SHLDR GLNSP STD 36MM; 180558, 354080, COMP NLK SCR 3.5HEX 4.75X20 ST; 113629, 318760, COMP PRIMARY STEM 9MM MINI. 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: 0001825034-2018-08620, 0001825034-2018-08621, 0001825034-2018-08623, 0001825034-2018-08626, 0001825034-2018-08627, 0001825034-2018-08625, 0001825034-2018-08624. PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL REVERSE SHOULDER ARTHROPLASTY. SUBSEQUENTLY THE PATIENT WAS REVISED TO A HEMI-SHOULDER AFTER AN INFECTION. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672347 ARCOM XL 44-36 STD HMRL BRNG PROSTHESIS, SHOULDER PHX ZIMMER BIOMET, INC. N/A 478460

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R