BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOM XL 44-36 STD HMRL BRNG

    MDR report key: 8184524 · Received December 20, 2018

    Report

    Report Number
    0001825034-2018-11371
    Event Type
    Injury
    Date Received
    December 20, 2018
    Date of Event
    May 25, 2017
    Report Date
    April 11, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PAO
    PMA / PMN Number
    K080642
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. UNIQUE IDENTIFIER (UDI) #: N/A. CONCOMITANT MEDICAL PRODUCTS: PART # 115340, COMP RVS HMRL TI TRAY 44MM, LOT # 963700; PART # 115330, COMP RVRS SHDR GLEN BSPLT +HA, LOT # 319980; PART # 118001, VERSA-DIAL/COMP TI STD TAPER, LOT # 739270; PART # 115385, COMP RVS CNTRL SCR 6.5X45MM ST; PART # 180502, COMP LOCKING SCREW 4.75X25MM, LOT # 532020; PART # 180511, COMP NON-LCKNG SCREW 4.75X35MM, LOT # 852750; PART # 180510, COMP NON-LCKNG SCREW 4.75X30MM, LOT # 852660; PART # 115313, COMP RVSR SHLDR GLNSP +3 36MM, LOT # 179470; PART # 113649, COMP PRIMARY STEM 9MM STD, LOT # 923820. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 11370.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 7 YEARS POST IMPLANTATION, THE PATIENT UNDERWENT A REVISION DUE TO PAIN, LOSS OF RANGE OF MOTION, AND FRACTURING OF THE HUMERAL TRAY. THE HUMERAL TRAY AND POLY LINER WERE THE ONLY COMPONENTS REVISED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1023593 ARCOM XL 44-36 STD HMRL BRNG PROSTHESIS, SHOULDER PAO ZIMMER BIOMET, INC. N/A 640710

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R