BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN OXFORD TIBIAL IMPLANT

    MDR report key: 17405832 · Received July 27, 2023

    Report

    Report Number
    3002806535-2023-00261
    Event Type
    Injury
    Date Received
    July 27, 2023
    Date of Event
    June 27, 2023
    Report Date
    September 25, 2023
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    N/A
    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). UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED A MEDWATCH REPORT SHOULD NOT HAVE BEEN FILED UNDER THE CURRENT MANUFACTURER AS THE PRODUCT IS NOT BIOMET UK LTD. DESIGN CONTROL. THIS EVENT WILL BE REPORTED ON: 0009613350 - 2023 - 00534. GIVEN THIS INFORMATION, THIS MEDWATCH WILL BE VOIDED.

    Additional Manufacturer Narrative · 0

    (B)(4). G2: FOREIGN: GERMANY. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. H3 OTHER TEXT : PRODUCT IS UNKNOWN.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THIS MDR WAS NOT FILED UNDER THE CURRENT MFR NUMBER. THE PRODUCT IS NOT UNDER BIOMET UK LTD. DESIGN CONTROL. THIS EVENT WILL BE REPORTED ON: 0009613350 - 2023 - 00534. GIVEN THIS INFORMATION, THIS MEDWATCH WILL BE VOIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE ARTHROPLASTY AND APPROXIMATELY 17 YEARS LATER A REVISION SURGERY WAS PERFORMED DUE TO THE FRACTURE OF THE TIBIAL COMPONENT. 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
    756277 UNKNOWN OXFORD TIBIAL IMPLANT KNEE PROSTHESIS NRA BIOMET UK LTD. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Required Intervention| H