BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SCREW

    MDR report key: 21856973 · Received April 17, 2025

    Report

    Report Number
    0001825034-2025-01122
    Event Type
    Injury
    Date Received
    April 17, 2025
    Date of Event
    March 21, 2025
    Report Date
    September 22, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    PHX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: MEDICAL PRODUCTS: ITEM#: 110032420, COMP AUG MINI BSPLT W TPR MD; LOT#: 64155087. ITEM#: 115396, COMP RVS CNTRL 6.5X30MM ST/RST; LOT#: 747480. ITEM#: UNKNOWN, UNKNOWN SCREW; LOT#: UNKNOWN. ITEM#: UNKNOWN, UNKNOWN SCREW; LOT#: UNKNOWN. ITEM#: UNKNOWN, UNKNOWN SCREW; LOT#: UNKNOWN. ITEM#: 115313, COMP RVSR SHLDR GLNSP +3 36MM; LOT#: 624810. ITEM#: 110031399, MINI STANDARD THICKNESS +0MM TAPER OFFSET 40MM DIAMETER HUMERAL TRAY; LOT#: 64425716. ITEM#: 110031424, STANDARD 36MM DIAMETER BEARING; LOT#: 64354409. G2: FOREIGN: AUSTRALIA. H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; D2; G2; G3; G6; H1; H2. UPON RECEIVING ADDITIONAL INFORMATION OF THE REPORTED EVENT, IT WAS DETERMINED THAT THE PRODUCT DID NOT CAUSE THE EVENT. THE INITIAL REPORT SHOULD BE VOIDED. 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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL SHOULDER ARTHROPLASTY APPROXIMATELY FIVE (5) YEARS AND THREE MONTHS AGO. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY A MONTH AGO DUE TO LOOSENING OF THE IMPLANTS. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AT THIS TIME.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1748173 UNKNOWN SCREW SHOULDER IMPLANT/EXTREMITIES PHX ZIMMER BIOMET, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Unknown Required Intervention| H SEE H11 NARRATIVE