BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASCENT CLSD BOX PS FMRL LG L

    MDR report key: 21222945 · Received January 23, 2025

    Report

    Report Number
    0001825034-2025-00194
    Event Type
    Injury
    Date Received
    January 23, 2025
    Date of Event
    October 2, 2024
    Report Date
    February 11, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    NA
    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 PRODUCT: BIOMET OFFSET TIBIAL TRAY 75MM, ITEM# 141484, LOT# 778140; BMT SPLINED KNEE STM 16X80, ITEM#141616, LOT# 010880; ASCENT REV FEM STEM 20X150, ITEM# 179075, LOT# 727740. G2- AUSTRALIA. H3- CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED. VISUAL EVALUATION OF THE PROVIDED PHOTOS FOUND EVIDENCE OF USE (SURGICAL DEBRIS); HOWEVER, NO FURTHER INFORMATION CAN BE DETERMINED. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. THE RADIOGRAPHS WERE NOT SUBMITTED AS THE IMAGES ARE UNDATED AND UNABLE TO BE CORRELATED WITH REPORTED EVENT. DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR DEVIATIONS AND/ OR ANOMALIES WITH NO DEVIATIONS / ANOMALIES IDENTIFIED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THIS COMPLAINT IS NOT CONFIRMED. IF ANY FURTHER INFORMATION IS RECEIVED WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL MEDWATCH WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE.TO MONITOR FOR TRENDS. H6: COMPONENT CODE: PROPOSED COMPONENT (ANNEX G) CODE IS: - MECHANICAL (G04) - FEMUR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY FOURTEEN YEARS POST IMPLANTATION DUE TO LOOSENING. THE PATIENT HAD TREATMENT FOR CANCER AND THE COMPONENT CAME LOOSE. IT'S NOT KNOWN WHY IMPLANT LOOSENED. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

    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
    420543 ASCENT CLSD BOX PS FMRL LG L PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. 541710

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention| H SEE H11.