BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVRS 25MM BSPLT HA+ADPTR

    MDR report key: 8501288 · Received April 10, 2019

    Report

    Report Number
    0001825034-2019-01641
    Event Type
    Injury
    Date Received
    April 10, 2019
    Date of Event
    April 13, 2016
    Report Date
    March 19, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    PMA / PMN Number
    K120121
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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 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.

    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.

    Description of Event or Problem · 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.

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT CODE - PHX. CONCOMITANT MEDICAL PRODUCTS: 115320 COMP RVRS SHLDR GLNSP STD 41MM 882260, 115375 COMP RVS TRAY +5MM CO 44MM 960740, XL-115366 ACROM XL 44-41 STD HMRL BRNG 637840, 180553 COMP LK SCR 3.5HEX 4.75X30 ST 448890, 115396 COMP RVS CNTRL 6.5X30MM ST/RST 54030, 180550 COMP LK SCR 3.5HEX 4.75X15 ST 209750, 180551 COMP LK SCR 3.5HEX 4.75X20 ST 706130, 180553 COMP LK SCR 3.5HEX 4.75X30 ST 4467890, 180554 COMP LK SCR 3.5HEX 4.75X35 ST 452510, 113672 COMP PRIMARY STEM 12 X 194 REV 147390, XL-115368 ARCOM XL 44-41 RTNV +3 HMRL BR 899260. THE COMPLAINT IS UNDER INVESTIGATION. ONCE THE INVESTIGATION IS COMPLETE A FOLLOW UP REPORT WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2019 - 01640, 0001825034 - 2019 - 01642, 0001825034 - 2019 - 01643.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A INITIAL RIGHT SHOULDER ARTHROPLASTY AND SUBSEQUENTLY UNDERWENT A REVISION DUE TO PAIN, LOSS OF RANGE OF MOTION AND LOOSENING ONE MONTH POST PRIMARY IMPLANTATION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294695 COMP RVRS 25MM BSPLT HA+ADPTR PROSTHESIS, SHOULDER PHX ZIMMER BIOMET, INC. N/A 425060

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R