BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPLOR 12X24 MM IMPLANT HEAD

    MDR report key: 21625567 · Received March 17, 2025

    Report

    Report Number
    0001825034-2025-00741
    Event Type
    Injury
    Date Received
    March 17, 2025
    Date of Event
    February 19, 2025
    Report Date
    July 24, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWI
    UDI-DI
    00880304438309
    PMA / PMN Number
    K051385
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT IS RECORDED BY ZIMMER BIOMET UNDER (B)(4). G2, COUNTRY EVENT OCCURRED IN: POLAND. COMPONENT CODES: PROPOSED G-CODE: MECHANICAL (G04) - STEM. D10 NARRATIVE: ITEM: 11-210062, LOT: 66363849, ITEM NAME: EXPLOR 7X26MM IMPL STEM W/SCR. COMPONENT CODES: PROPOSED G-CODE: MECHANICAL (G04) - HEAD. THE PRODUCT IS IN THE PROCESS OF BEING EVALUATED BY ZIMMER BIOMET. ONCE THE PRODUCT INVESTIGATION HAS BEEN COMPLETED, A FOLLOW UP/FINAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS EVENT IS RECORDED BY ZIMMER BIOMET UNDER (B)(4). THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4, B5, G1, G3, G6, H2, H11. THE FOLLOWING SECTIONS HAVE BEEN CORRECTED: H6, H11. G2, COUNTRY EVENT OCCURRED IN: POLAND. COMPONENT CODES: PROPOSED G-CODE: MECHANICAL (G04) - HEAD. D10 NARRATIVE: ITEM: 11-210062, LOT: 66363849, ITEM NAME: EXPLOR 7X26MM IMPL STEM W/SCR. THE PRODUCT IS IN THE PROCESS OF BEING EVALUATED BY ZIMMER BIOMET. ONCE THE PRODUCT INVESTIGATION HAS BEEN COMPLETED, A FOLLOW UP/FINAL REPORT WILL BE SUBMITTED.

    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 THE PATIENT WAS IMPLANTED WITH A PROSTHESIS. SUBSEQUENTLY, THE PATIENT SUFFERED A FRACTURE AND THE IMPLANT BECAME LOOSE. THERE WAS HARM TO THE PATIENT AS THE PATIENT HAD TO UNDERGO ADDITIONAL SURGICAL/MEDICAL PROCEDURE. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THE INCIDENT.

    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
    1565962 EXPLOR 12X24 MM IMPLANT HEAD PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER KWI ZIMMER BIOMET, INC. 895100 00880304438309

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Hospitalization| R SEE H11 NARRATIVE