BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALL-POLY PATELLA CEMENTED 29 MM DIAMETER

    MDR report key: 22131033 · Received June 3, 2025

    Report

    Report Number
    0002648920-2025-00150
    Event Type
    Injury
    Date Received
    June 3, 2025
    Date of Event
    July 23, 2024
    Report Date
    October 23, 2025
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    MBH
    UDI-DI
    00889024247680
    PMA / PMN Number
    K172524
    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. FEMUR CEMENTED (CR) STANDARD NITRIDED RIGHT SIZE 7, ITEM# 42572606202, LOT# 65148467. ARTICULAR SURFACE (MC) RIGHT 10 MM HEIGHT, ITEM# 42522100410, LOT# 63845996. 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.

    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 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
    431655 ALL-POLY PATELLA CEMENTED 29 MM DIAMETER PROSTHESIS, KNEE MBH ZIMMER MANUFACTURING B.V. 65134430 00889024247680

    Patients

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