BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF UNI TIB TRAY SZA LM

    MDR report key: 17842324 · Received September 29, 2023

    Report

    Report Number
    3002806535-2023-00326
    Event Type
    Injury
    Date Received
    September 29, 2023
    Date of Event
    September 7, 2023
    Report Date
    October 17, 2023
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    UDI-DI
    05019279388844
    PMA / PMN Number
    P010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10 ¿ OXF ANAT BRG LT SM SIZE 4 PMA; ITEM#: 159541, LOT#: 811040 OXF TWIN-PEG CMNTD FEM SM PMA; ITEM#: 161468, LOT#: 175150 UNKNOWN CEMENT 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. 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 THAT COULD BE RELATED TO THE REPORTED EVENT. DEVICE IS USED FOR TREATMENT. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A RADIOLOGIST. THREE VIEWS OF THE LEFT KNEE DEMONSTRATE A MEDIAL COMPARTMENT HEMIARTHROPLASTY WITH SUBSIDENCE OF THE MEDIAL TIBIAL COMPONENT WITH RADIOLUCENCY ALONG THE CEMENT HARDWARE INTERFACE CONSISTENT WITH LOOSENING. MODERATE JOINT EFFUSION AND OSTEOPENIA WAS ALSO NOTED. 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 THE PATIENT UNDERWENT REVISION SURGERY TO A TOTAL KNEE APPROXIMATELY ONE YEAR AND FIVE MONTHS POST INITIAL LEFT PARTIAL KNEE REPLACEMENT, DUE TO TIBIAL BASEPLATE LOOSENING. POOR BONE QUALITY WAS NOTED DURING THE SURGERY. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    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
    2278488 OXF UNI TIB TRAY SZA LM PROSTHESIS, KNEE, FEMOROTIBIAL, UNICOMPARTMENTAL NRA BIOMET UK LTD. N/A 281270 05019279388844

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention| H