BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF UNI TIB TRAY SZA RM/LL PMA

    MDR report key: 9368633 · Received November 25, 2019

    Report

    Report Number
    3002806535-2019-00888
    Event Type
    Injury
    Date Received
    November 25, 2019
    Date of Event
    October 31, 2019
    Report Date
    December 19, 2019
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    P010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT KNEE ARTHROPLASTY ON UNKNOWN DATE IN (B)(6) 2011. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED DUE TO LATERAL PROGRESSION.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: OXF TWIN-PEG CMNTD FEM SM PMA CATALOG #: 161468 LOT #: 140990, MEDICAL PRODUCT: OXF ANAT BRG RT SM SIZE 4 PMA CATALOG #: 159569 LOT #: 923050. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2019-00887, 3002806535-2019-00889. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT KNEE ARTHROPLASTY ON UNKNOWN DATE IN (B)(6) 2011. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED DUE TO LATERAL PROGRESSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1165595 OXF UNI TIB TRAY SZA RM/LL PMA KNEE PROSTHESIS NRA BIOMET UK LTD. N/A 702940

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R