BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF ANAT BRG LT X-SM SZ 3 PMA

    MDR report key: 15402117 · Received September 12, 2022

    Report

    Report Number
    3002806535-2022-00385
    Event Type
    Injury
    Date Received
    September 12, 2022
    Date of Event
    June 22, 2022
    Report Date
    September 16, 2022
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    UDI-DI
    05019279068937
    PMA / PMN Number
    P010014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: OXF TWIN-PEG CMNTD FEM XS PMA , ITEM# 161467 , 492840, OXF UNI TIB TRAY SZ AA LM PMA , ITEM# 159531 , LOT# 105880. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535 -2022 -00384, 3002806535 -2022 -00386. 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

    (B)(4). REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. DEVICES ARE USED FOR TREATMENT. 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 THE PATIENT UNDERWENT A LEFT KNEE REVISION 27 MONTHS POST-IMPLANTATION DUE TO PAIN. 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
    1307114 OXF ANAT BRG LT X-SM SZ 3 PMA KNEE PROTHESIS NRA BIOMET UK LTD. N/A 600760 05019279068937

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R