BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE SHOULDER HUMERAL BEARING ARCOM XL

    MDR report key: 7014798 · Received November 9, 2017

    Report

    Report Number
    0001825034-2017-10071
    Event Type
    Injury
    Date Received
    November 9, 2017
    Date of Event
    October 23, 2015
    Report Date
    January 29, 2018
    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
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: COMP LK SCR 3.5HEX 4.75X30 ST, LOT#820860, ITEM#180553, COMP LK SCR 3.5HEX 4.75X25 ST, LOT#039010, ITEM# 180552, COMP LK SCR 3.5HEX 4.75X15 ST, LOT#820680 ITEM#180550, COMP LK SCR 3.5HEX 4.75X15 ST, LOT#850920, ITEM#180550, COMP RVS CNTRL 6.5X35MM ST/RST, LOT#430520, ITEM#115397, COMP RVS TRAY CO 44MM, LOT#951720, ITEM#115370, COMP RVRS 25MM BSPLT HA+ADPTR, LOT#793530, ITEM#010000589, COMP PRIMARY STEM 9MM STD, LOT#153780, ITEM#113649. THE REPORTED EVENT COULD NOT BE CONFIRMED BASED ON LIMITED INFORMATION RECEIVED. NO PRODUCTS WERE RETURNED; THEREFORE, THE VISUAL AND DIMENSIONAL INSPECTIONS WERE NOT PERFORMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. COMPATIBILITY CHECK NOTED NO ISSUES. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(4). COMCOMITANT PRODUCTS: COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE STD 36MM PN: 115310 LN:969190. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT INITIAL RIGHT REVERSE TOTAL SHOULDER REPLACEMENT. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792887 COMPREHENSIVE REVERSE SHOULDER HUMERAL BEARING ARCOM XL PROSTHESIS, SHOULDER PAO ZIMMER BIOMET, INC. N/A 599600

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10