BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD UNI FEMORAL SM

    MDR report key: 16722472 · Received April 12, 2023

    Report

    Report Number
    3002806535-2023-00091
    Event Type
    Injury
    Date Received
    April 12, 2023
    Date of Event
    December 29, 2022
    Report Date
    April 4, 2023
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    UDI-DI
    05019279001248
    PMA / PMN Number
    P010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: OXF ANAT BRG RT SM SIZE 5 PMA ITEM#159570 LOT#3032998. OXF UNI TIB TRAY SZ C RM PMA ITEM#154723 LOT#3922418. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2023-00017-1. THE FEMORAL COMPONENT REMAINS IMPLANTED AND THEREFORE NOT RETURNED SO VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS FOR THE FEMORAL COMPONENT CONFIRMED NO ABNORMALITIES OR DEVIATIONS. DEVICE IS USED FOR TREATMENT. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A RADIOLOGIST. SIGNIFICANT FINDINGS INCLUDE SUBLUXATION OF THE FEMORAL COMPONENT AS WELL AS DISPLACED POLYETHYLENE LINING ON THE LATER TIME POINT. THE ORIGINAL TIME POINTS DEMONSTRATE POSSIBLE IMPROPER SIZING OF THE HARDWARE FOR THE BONES. WITH THE AVAILABLE INFORMATION, 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 PATIENT UNDERWENT RIGHT KNEE REVISION SURGERY DUE TO LUXATION, APPROXIMATELY FIVE (5) YEARS AND NINE (9) MONTHS FROM INITIAL IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2283648 OXFORD UNI FEMORAL SM KNEE PROTHESIS NRA BIOMET UK LTD. N/A J3877349 05019279001248

    Patients

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