BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVS TRAY +10MM CO 44MM

    MDR report key: 9270702 · Received November 3, 2019

    Report

    Report Number
    0001825034-2019-04957
    Event Type
    Injury
    Date Received
    November 3, 2019
    Report Date
    April 4, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    UDI-DI
    00880304543195
    PMA / PMN Number
    K113069
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). UPON FURTHER ASSESSMENT IT WAS DISCOVERED THAT THIS IMPLANT WAS NOT IN SITU WHEN THE PATIENT COMPLAINED OF FURTHER PAIN. IT HAD ALREADY BEEN EXPLANTED. THEREFORE IT WILL BE VOIDED.

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG #: 180561, COMP NLK SCR 3.5HEX 4.75X35 ST, LOT # 251830, CATALOG #: 180552, COMP LK SCR 3.5HEX 4.75X25 ST, LOT # 593030, CATALOG #: 180553, COMP LK SCR 3.5HEX 4.75X30 ST, LOT # 472190, CATALOG #: 180560, COMP NLK SCR 3.5HEX 4.75X30 ST, LOT # 541780. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-04986, 0001825034-2019-04987, 0001825034-2019-04988, 0001825034-2019-04991.

    Description of Event or Problem · 0

    UPON FURTHER ASSESSMENT IT WAS DISCOVERED THAT THIS IMPLANT WAS NOT IN SITU WHEN THE PATIENT COMPLAINED OF FURTHER PAIN. THEREFORE IT WILL 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) UDI# (B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG #: 115310, COMP RVRS SHLDR GLNSP STD, LOT # 670930, CATALOG #: 115397, COMP RVS CNTRL, LOT # 172790, CATALOG #: 115330, COMP RVRS SHDR GLEN BSPLT, LOT # 415440, CATALOG #: 113653, COMP PRIMARY STEM 13MM STD, LOT # 921870, CATALOG #: 118001, VERSA-DIAL/COMP TI STD TAPER, LOT # 411920, CATALOG #: EP-115395, E1 44-36 RTNV +3 HMRL BRG, LOT # 386560. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2019-04951, 0001825034-2019-04952, 0001825034-2019-04953, 0001825034-2019-04954, 0001825034-2019-04955, 0001825034-2019-04956, 0001825034-2019-04957. REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT IS STILL EXPERIENCING PAIN APPROXIMATELY TWO YEARS POST-IMPLANTATION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1065018 COMP RVS TRAY +10MM CO 44MM PROSTHESIS SHOULDER KWS ZIMMER BIOMET, INC. N/A 800090 00880304543195

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other