BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD UNI TIB TRAY 38X26 RLLM

    MDR report key: 19709020 · Received July 10, 2024

    Report

    Report Number
    3002806535-2024-00259
    Event Type
    Injury
    Date Received
    July 10, 2024
    Date of Event
    June 11, 2024
    Report Date
    August 2, 2024
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    UDI-DI
    05019279388110
    PMA / PMN Number
    P010014
    Adverse Event
    Yes
    Product Problem
    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 AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D6, D10, G3, G6, H2, H3, H4, H6, H11. D10: LOT NUMBER PROVIDED FOR THE FOLLOWING PRODUCT: ITEM# 154621; LOT# 529804; OXFORD UNI TIB BRG SM SZ6. 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. REVIEW OF THE COMPLAINT HISTORIES FOUND NO ADDITIONAL RELATED COMPLAINTS FOR THESE ITEMS AND THE REPORTED PART AND LOT COMBINATIONS. 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) D10: ITEM# 154600; LOT# 833703; OXFORD UNI FEMORAL SM ITEM# 154621; LOT# UNKNOWN; OXFORD UNI TIB BRG SM SZ6 ITEM#3021170001; LOT# 60483569; REFOBACIN PLUS BONE CEMENT 40X2 G2 ¿ FOREIGN ¿ NEW ZEALAND 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 WEAR PROBLEMS, APPROXIMATELY 19 YEARS AND 7 MONTHS POST-IMPLANTATION. 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
    1133414 OXFORD UNI TIB TRAY 38X26 RLLM KNEE PROSTHESIS NRA BIOMET UK LTD. N/A 375961 05019279388110

    Patients

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