BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEG FULLY THREAD 2.5MM X 22

    MDR report key: 23817458 · Received December 16, 2025

    Report

    Report Number
    0001825034-2025-03997
    Event Type
    Injury
    Date Received
    December 16, 2025
    Date of Event
    October 24, 2025
    Report Date
    April 28, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HRS
    UDI-DI
    00887868452710
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: B4; B5; D2; G1; G3; G6; H1; H2; H3; H6; H10. THE REPORTED CANNOT BE CONFIRMED. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. MEDICAL RECORDS WERE NOT PROVIDED. THE DEVICE FUNCTIONED AS INTENDED WITHOUT AN ALLEGATION PRIOR TO THE SURGICAL PROCEDURE FOR REMOVAL PER PATIENT'S REQUEST, THIS REVISION IS CONSIDERED NOT DEVICE RELATED. NO PROBLEM WAS FOUND WITH THE REPORTED IMPLANTS. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). G2: FOREIGN, THE EVENT OCCURRED IN JAPAN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. ASSOCIATED REPORTS ARE AVAILABLE FOR THE APPLICABLE CONCOMITANT PRODUCTS BELOW IN THE D10 NARRATIVE. D10: CONCOMITANT MEDICAL PRODUCTS, PART (LOT): 131212518(493730), 131212520(379480), 131212526(874550), 131212618(66123452), 851318500(66288566). THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT 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 REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INITIAL OPERATION WAS PERFORMED WITH ALPS PLATE. THE FRACTURE SITE HEALED, AND THE PATIENT DESIRED REMOVAL OF THE PLATE. THEREFORE, THE REMOVAL SURGERY WAS PERFORMED APPROXIMATELY 15 MONTHS POST IMPLANTATION. DURING THE REMOVAL SURGERY, NONE OF THE SCREWS COULD BE EXPLANTED. AS A CONSEQUENCE, THE PROCEDURE WAS ABORTED AND THE SURGEON HAS DETERMINED THAT REMOVAL OF THE PRODUCT IS NOT FEASIBLE, AND NO FUTURE SURGERY IS PLANNED AT THE MOMENT. IT HAS NOT BEEN CONFIRMED WHETHER ANY FRAGMENTS REMAIN. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2444698 PEG FULLY THREAD 2.5MM X 22 PLATE, FIXATION, BONE HRS ZIMMER BIOMET, INC. 65993168 00887868452710

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other SEE H11