BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF ANAT BRG RT LG SIZE 3 PMA

    MDR report key: 18355108 · Received December 19, 2023

    Report

    Report Number
    3002806535-2023-00448
    Event Type
    Injury
    Date Received
    December 19, 2023
    Date of Event
    December 4, 2023
    Report Date
    January 16, 2024
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    UDI-DI
    05019279786282
    PMA / PMN Number
    P010014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED GOOD BONY COVERAGE OF THE TIBIAL TRAY. THE SUBSTRATE INSIDE OF PERIMETER RAIL APPEARS TO HAVE SIGNIFICANT BONE ATTACHED TO THE INFERIOR SURFACES AND AROUND THE KEEL. TIBIAL TRAY APPEARS TO HAVE BEEN WELL FIXED TO PATIENTS TIBIA. THE FEMUR APPEARS TO HAVE MINIMAL BONE ONGROWTH. THIS COULD BE DUE TO PATIENTS BONE QUALITY E.G. OSTEOPOROTIC OR SIMILAR, HOWEVER BASED ON THE PROVIDED PHOTOGRAPHS THIS CANNOT BE CONFIRMED AS ROOT CAUSE. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS THAT COULD BE RELATED TO THE REPORTED EVENT. DEVICES ARE USED FOR TREATMENT. REPORTED EVENT DID NOT OCCUR IN AN OPERATING ROOM OR AS PART OF A MEDICAL PROCEDURE; THEREFORE, NO MEDICAL RECORDS ARE AVAILABLE FOR REVIEW. WITH THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE COULD NOT 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). G2-FOREIGN- NEW ZEALAND. D10. ITEM#: 166579; LOT#: 6052528; ITEM NAME: OXF UNI CMNTLS TIB SZ E RM; ITEM#: 154927; LOT#: 6047141; ITEM NAME: OXFORD PH3 CEMENTLESS FEM SZ L. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE THE ASSOCIATED REPORTS: 3002806535 - 2023 - 00445, 3002806535 - 2023 - 00446. 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 THE PATIENT UNDERWENT REVISION SURGERY DUE TO PAIN. 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
    1139148 OXF ANAT BRG RT LG SIZE 3 PMA PROSTHESIS, KNEE NRA BIOMET UK LTD. 6042985 05019279786282

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Hospitalization| R