BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPLOR 7X26MM IMPL STEM W/SCR

    MDR report key: 21035348 · Received December 30, 2024

    Report

    Report Number
    0001825034-2024-03060
    Event Type
    Injury
    Date Received
    December 30, 2024
    Date of Event
    January 4, 2019
    Report Date
    April 30, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWI
    PMA / PMN Number
    K051385
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H2, H3, H6, H11 H6: MECHANICAL (G04) - STEM 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. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE REPORTED EVENT NOT CONFIRMED. 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.

    Additional Manufacturer Narrative · 0

    CMP-(B)(4). D10: EXPLOR 12X24 MM IMPLANT HEAD CAT# 11-210042 LOT# 071500. G2: NORWAY. H4: APPROX IMPLANT DATE IS 2014. 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D6A, G3, G6, H2, H10, H11 ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    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 A PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 5 YEARS POST IMPLANTATION DUE TO GRADUAL PAIN AND ROM ISSUES. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2437015 EXPLOR 7X26MM IMPL STEM W/SCR PROSTHESIS, ELBOW KWI ZIMMER BIOMET, INC. NI 741190

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R SEE H11