BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVS TRAY CO 44MM

    MDR report key: 8421513 · Received March 14, 2019

    Report

    Report Number
    0001825034-2019-01174
    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
    KWS
    PMA / PMN Number
    K113069
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT CODE: PHX. 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; EP-115397, E1 44-41 STD +3 HMRL BRG, LOT 230960; 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 - 01176.

    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
    213116 COMP RVS TRAY CO 44MM PROSTHESIS, SHOULDER KWS ZIMMER BIOMET, INC. N/A 448500

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R