BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMUR CEMENTED (CR) STANDARD NITRIDED RIGHT SIZE 7

    MDR report key: 22131023 · Received June 3, 2025

    Report

    Report Number
    0001822565-2025-01649
    Event Type
    Injury
    Date Received
    June 3, 2025
    Date of Event
    July 23, 2024
    Report Date
    October 23, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00889024576179
    PMA / PMN Number
    K193223
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10-MEDICAL PRODUCT TIBIA CEMENTED 5 DEGREE STEMMED RIGHT SIZE C ITEM# 42532006402 LOT# 65282268 ARTICULAR SURFACE (MC) RIGHT 10 MM HEIGHT ITEM# 42522100410 LOT# 63845996 ALL-POLY PATELLA CEMENTED 29 MM DIAMETER ITEM# 42540200029 LOT# 65134430 PALACOS MV 1X40 US ITEM# 5087347 LOT# 97971007 PALACOS MV+G 1X40 US ITEM# 5051207 LOT# 96794917 H3- 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. H6: COMPONENT CODE: PROPOSED COMPONENT (ANNEX G) CODE IS: - MECHANICAL (G04) - FEMUR.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. UPDATED: B4, B5, D2, G1, G3, G6, H1, H2, H3, H6, H10, AND H11. CORRECTED: H4. NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; THEREFORE, VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: IT WAS REPORTED PROGRESSIVE/PERSISTENT MODERATE PAIN, STARTED ON MEDROL DOS PAK, AND RESOLVED. ALONG WITH WORSENING LOWER BACK PAIN (NOT RELATED TO STUDY KNEE). REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THIS COMPLAINT IS 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PROGRESSIVE PERSISTENT PAIN AND WAS PRESCRIBED MEDICATION APPROXIMATELY TWO YEARS AND THREE MONTHS POST IMPLANTATION. THE PATIENT WAS PRESCRIBED MEDROL DOS PAK AND THE ISSUE RESOLVED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS 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
    358595 FEMUR CEMENTED (CR) STANDARD NITRIDED RIGHT SIZE 7 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. 65148467 00889024576179

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other SEE H11.