BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E1 44-41 STD +3 HMRL BRG

    MDR report key: 8421755 · Received March 14, 2019

    Report

    Report Number
    0001825034-2019-01176
    Event Type
    Injury
    Date Received
    March 14, 2019
    Date of Event
    April 24, 2014
    Report Date
    June 11, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PAO
    PMA / PMN Number
    K113121
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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). 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: PM555222, HERBERT PM COMPR RVS HA BP, LOT: 728920; 118001, VERSA-DIAL/COMP TI STD TAPER, LOT: 194470; 113648, COMP PRIMARY STEM 8MM STD, LOT: 864660; 115323, COMP RVSR SHLDR GLNSP +3 41MM, LOT: 788010; 115370, COMP RVS TRAY CO 44MM, LOT: 448500; 115386, COMP RVS CNTRL SCR 6.5X50MM ST, LOT: 269000; 180554, COMP LK SCR 3.5HEX 4.75X35 ST, LOT: 729380; 180554, COMP LK SCR 3.5HEX 4.75X35 ST, LOT: 932440; 180552, COMP LK SCR 3.5HEX 4.75X25 ST, LOT: 376810; 180556, COMP LK SCR 3.5HEX 4.75X45 ST, LOT: 620150. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2019 - 01170, 0001825034 - 2019 - 01171, 0001825034 - 2019 - 01172, 0001825034 - 2019 - 01173, 0001825034 - 2019 - 01174.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 5 YEARS POST IMPLANTATION, THE PATIENT HAS BEEN INDICATED FOR A SHOULDER REVISION DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213141 E1 44-41 STD +3 HMRL BRG PROSTHESIS, SHOULDER PAO ZIMMER BIOMET, INC. N/A 230960

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R