BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPLOR 8X28MM IMPL STEM W/SCR

    MDR report key: 18645370 · Received February 5, 2024

    Report

    Report Number
    0001825034-2024-00302
    Event Type
    Injury
    Date Received
    February 5, 2024
    Date of Event
    December 21, 2023
    Report Date
    April 26, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWI
    PMA / PMN Number
    K040611
    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). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2023-02248-1. D10: MEDICAL PRODUCTS: ITEM#: 11-210041, EXPLOR 10X24 MM IMPLANT HEAD; LOT#: 420100. G2: FOREIGN: AUSTRALIA. H3: CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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 INFORMATION. H6: COMPONENT CODES: MECHANICAL (G04) - STEM. NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: DISASSOCIATION OF THE RADIAL HEAD REPLACEMENT FROM THE STEM AND A DISPLACED SURGICAL SCREW AS NOTED. OSSEOUS IRREGULARITY OF THE DISTAL HUMERUS LIKELY AT THE CAPITELLUM POSSIBLY SECONDARY TO THE IMPLANT DISASSOCIATION. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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 ELBOW ARTHROPLASTY APPROXIMATELY TWO (2) YEARS AGO. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO THE DISASSOCIATION OF THE IMPLANTS AND MIGRATION OF THE IMPLANT INTO THE JOINT SPACE WHICH CAUSED CONSIDERABLE DAMAGE AND BONE LOSS TO THE ARTICULAR SURFACE OF THE DISTAL "HUMERUS".

    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
    2079945 EXPLOR 8X28MM IMPL STEM W/SCR PROSTHESIS, ELBOW, HEMI, RADIAL, POLYMER/EXTREMITIES KWI ZIMMER BIOMET, INC. 680450

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male Hospitalization| R SEE H10 NARRATIVE.