BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP NON-LCKNG SCREW 4.75X40MM

    MDR report key: 13523133 · Received February 14, 2022

    Report

    Report Number
    0001825034-2022-00311
    Event Type
    Injury
    Date Received
    February 14, 2022
    Date of Event
    August 27, 2019
    Report Date
    March 2, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    PMA / PMN Number
    K113069
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). PRO CODE: PHX. CONCOMITANT MEDICAL PRODUCTS: COMP PRIMARY STEM 13MM STD CAT# 113653 LOT#399260, VERSA-DIAL/COMP TI STD TAPER CAT# 118001 LOT# 168410, COMP RVRS SHLDR GLNSP STD 41MM CAT# 115320 LOT# 397490, ACROM XL 44-41 STD HMRL BRNG CAT# XL-115366 LOT# 742400, COMP RVS HMRL TI TRAY 44MM CAT# 115340 LOT# 988750, COMP RVS CNTRL SCR 6.5X45MM ST CAT# 115385 LOT# 683180, COMP NON-LCKNG SCREW 4.75X40MM CAT# 180512 LOT# 490220, COMP LOCKING SCREW 4.75X25MM CAT# 180502 LOT# 719990, COMP LOCKING SCREW 4.75X25MM CAT# 180502 LOT# 719990, COMP LOCKING SCREW 4.75X30MM CAT# 180503 LOT# 003710, COMP NON-LCKNG SCREW 4.75X35MM CAT# 180511 LOT# 064300. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2022 - 00305, 0001825034 - 2022 - 00306, 0001825034 - 2022 - 00307, 0001825034 - 2022 - 00308, 0001825034 - 2022 - 00309, 0001825034 - 2022 - 00310, 0001825034 - 2022 - 00312, 0001825034 - 2022 - 00313, 0001825034 - 2022 - 00314, 0001825034 - 2022 - 00315, 0001825034 - 2022 - 00316.

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, THIS REPORT SHOULD BE VOIDED AS IT WAS DETERMINED TO BE A DUPLICATE COMPLAINT. EVENT WILL BE CAPTURED UNDER MFR NUMBER: 0001825034 - 2022 - 00452, 0001825034 - 2022 - 00453 , 0001825034 - 2022 - 00454, 0001825034 - 2022 - 00455, 0001825034 - 2019 - 05285-3, 0001825034 - 2022 - 00456, 0001825034 - 2022 - 00457, 0001825034 - 2022 - 00458, 0001825034 - 2022 - 00459, 0001825034 - 2022 - 00460, 0001825034 - 2022 - 00461, 0001825034 - 2022 - 00462.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 7.5 YEARS POSTIMPLANTATION DUE TO PAIN. DURING THE REVISION, METAL DEBRIS WAS NOTED, THE WELL FIXED STEM WAS EXPLANTED, AND A PROXIMAL HUMERAL FRACTURE OCCURRED AND REPAIRED. ALL COMPONENTS WERE EXCHANGED WITHOUT COMPLICATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75092 COMP NON-LCKNG SCREW 4.75X40MM SHOULDER PROSTHESIS SCREW PHX ZIMMER BIOMET, INC. NI 919380

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| H