BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD UNI TIB TRAY SZA RM

    MDR report key: 22218794 · Received June 17, 2025

    Report

    Report Number
    3002806535-2025-00238
    Event Type
    Injury
    Date Received
    June 17, 2025
    Date of Event
    June 12, 2025
    Report Date
    October 29, 2025
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    UDI-DI
    05019279388851
    PMA / PMN Number
    P010014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10 ¿ 154912, OXF PH3 CEMENTLESS FEM SZ XSM, LOT 7237890. 160792, OXF ANAT BRG RT X-SM 5MM PMA, LOT 6786762. G2 ¿ FOREIGN ¿ JAPAN. 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, G3, G6, H2, H3, H6, H10, H11. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; A PRODUCT EVALUATION COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS THAT COULD BE RELATED TO THE REPORTED EVENT. THE REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS. RADIOGRAPHS WERE PROVIDED AND REVIEWED. THE REVIEW IDENTIFIED POSTOPERATIVE SHORT AP X-RAY SHOWS SLIGHT VARUS ALIGNMENT OF THE TIBIAL COMPONENT AND GROSSLY NEUTRAL FEMOROTIBIAL KNEE JOINT ALIGNMENT RATHER THAN STANDARD NORMAL VALGUS ALIGNMENT OF THE KNEE. ON LATER IMAGING, THE BEARING IS ANTERIORLY DISLOCATED. IT IS UNCERTAIN IF THE MILD RELATIVE VARUS ALIGNMENT OF THE KNEE COULD HAVE LED TO BEARING WEAR PREDISPOSING TO BEARING DISLOCATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORIES IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEMS AND NO ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED PART AND LOT COMBINATIONS. A DEFINITIVE ROOT CAUSE CANNOT 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY THREE MONTHS POST IMPLANTATION DUE TO PAIN AND BEARING DISLOCATED ANTERIORLY. ALL IMPLANTS WERE REVISED. NO ADDITIONAL 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
    1593626 OXFORD UNI TIB TRAY SZA RM PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL NRA BIOMET UK LTD. J7792994 05019279388851

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Required Intervention| H SEE H11 NARRATIVE.