BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD PH3 CEMENTLESS FEM SZ L

    MDR report key: 23462227 · Received November 4, 2025

    Report

    Report Number
    3002806535-2025-00526
    Event Type
    Injury
    Date Received
    November 4, 2025
    Date of Event
    October 8, 2025
    Report Date
    February 10, 2026
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    UDI-DI
    00887868353789
    PMA / PMN Number
    P010014
    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). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE PRODUCT INVOLVED IN THE REPORTED EVENT WAS NOT RETURNED FOR INVESTIGATION; HOWEVER, PICTURES WERE PROVIDED AND CONFIRM THE PRODUCT IDENTIFICATION ENGRAVING ON THE PRODUCT AND ON THE LABEL. THE PICTURES SHOW THE BEARING AND THE FEMORAL COMPONENT. THERE APPEARS TO BE WITNESS OF SOME BONY INGROWTH ON THE FEMORAL COMPONENT HOWEVER THIS CANNOT BE CONFIRMED DUE TO THE POOR THE QUALITY OF THE PHOTOS. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. REVIEW OF THE COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED COMPLAINTS FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: ITEM NAME# OXF ANAT BRG LT LG SIZE 4 PMA; ITEM NUMBER# 159555; LOT NUMBER# 7802829. ITEM NAME# UNKNOWN TIBIAL COMPONENT; ITEM NUMBER# UNKNOWN; LOT NUMBER# UNKNOWN. G2 ¿ FOREIGN ¿ AUSTRALIA. 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.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT KNEE REVISION SURGERY DUE TO A LOOSE UNCEMENTED OXFORD FEMORAL COMPONENT. BOTH THE BEARING AND FEMORAL COMPONENT WERE EXPLANTED. LOOSENING WAS LIMITED TO THE FEMORAL COMPONENT. APPROXIMATELY 1-YEAR POST-IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND ALL ADDITIONAL INFORMATION RECEIVED HAS BEEN INCLUDED IN THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212923 OXFORD PH3 CEMENTLESS FEM SZ L PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL, SEMI-CONSTRAINED NRA BIOMET UK LTD. 7747856 00887868353789

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R