BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF ANAT BRG RT MD SIZE 6 PMA MED SZ 6

    MDR report key: 8549042 · Received April 25, 2019

    Report

    Report Number
    3002806535-2019-00405
    Event Type
    Injury
    Date Received
    April 25, 2019
    Date of Event
    March 28, 2019
    Report Date
    August 20, 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
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. PRODUCT NOT RETURNED DUE TO HOSPITAL POLICY. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    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 PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO LATERAL WEAR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT KNEE PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO LATERAL WEAR.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: OXF UNI TIB TRAY SZ CRM PMA, CATALOG #: 154723, LOT #: 072450. MEDICAL PRODUCT: OXF TWIN-PEG CMNTD FEM MD PMA EM MED, CATALOG #:161469, LOT #: 781120. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2019-00406, 3002806535-2019-00407. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. PRODUCT NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT KNEE PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO UNKNOWN REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341137 OXF ANAT BRG RT MD SIZE 6 PMA MED SZ 6 KNEE PROSTHESIS NRA BIOMET UK LTD. N/A 533720

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R