BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP LOCKING SCREW 4.75X30MM

    MDR report key: 13685596 · Received March 7, 2022

    Report

    Report Number
    0001825034-2022-00461
    Event Type
    Injury
    Date Received
    March 7, 2022
    Date of Event
    August 27, 2019
    Report Date
    March 29, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    PMA / PMN Number
    K113069
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). PROCODE: 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#: 919380. 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 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: 0001825034-2022-00452, 0001825034-2022-00453, 0001825034-2022-00454, 0001825034-2022 00455, 0001825034-2019-05285, 0001825034-2022-00456, 0001825034-2022-00457, 0001825034-2022-00458, 0001825034-2022-00459, 0001825034-2022-00460, 0001825034-2022-00462.

    Additional Manufacturer Narrative · 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.

    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
    1287434 COMP LOCKING SCREW 4.75X30MM PROSTHESIS, SHOULDER PHX ZIMMER BIOMET, INC. NI 003710

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| H SEE H10