BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF UNI TIB TRAY SZ D LM PMA

    MDR report key: 17938000 · Received October 16, 2023

    Report

    Report Number
    3002806535-2023-00350
    Event Type
    Injury
    Date Received
    October 16, 2023
    Date of Event
    September 21, 2023
    Report Date
    October 26, 2023
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    UDI-DI
    05019279388905
    PMA / PMN Number
    P010014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. THE DEVICE IS USED FOR TREATMENT. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A RADIOLOGIST. THERE IS A MEDIAL UNICOMPARTMENTAL ARTHROPLASTY WITH A MEDIALLY SUBSIDED AND LOOSE TIBIAL IMPLANT. RADIOLUCENCY IS PRESENT AT THE CENTRAL TIBIAL PLATEAU. THERE IS MILD KNEE VARUS. LOOSENING AND SUBSIDENCE OF THE TIBIAL IMPLANT OF THE MEDIAL UNICOMPARTMENTAL ARTHROPLASTY. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). D10: OXF TWIN-PEG CMNTD FEM LG PMA; REF#161470; LOT#056160. OXF ANAT BRG LT LG SIZE 5 PMA; REF#159556; LOT#2944765. 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 APPROXIMATELY 9 YEARS AND 5 MONTHS POST-IMPLANTATION, THE PATIENT UNDERWENT REVISION SURGERY FROM A PARTIAL KNEE TO A TOTAL KNEE DUE TO PAIN, ASEPTIC LOOSENING, TIBIAL BONE COLLAPSE, AND A CYST FORMING. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2116749 OXF UNI TIB TRAY SZ D LM PMA KNEE PROSTHESIS NRA BIOMET UK LTD. N/A 945640 05019279388905

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| H SEE H10 NARRATIVE