BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF ANAT BRG RT X-SM 3MM PMA

    MDR report key: 10384526 · Received August 10, 2020

    Report

    Report Number
    3002806535-2020-00371
    Event Type
    Injury
    Date Received
    August 10, 2020
    Date of Event
    August 5, 2020
    Report Date
    August 19, 2020
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    UDI-DI
    05019279073016
    PMA / PMN Number
    P010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D11: ASSOCIATED PRODUCTS: MEDICAL PRODUCT: OXF UNI TIB TRAY SZ AA RM PMA, CATALOG #: 159532, LOT #: 434130; MEDICAL PRODUCT: OXF TWIN-PEG CMNTD FEM XS PMA, CATALOG #: 161467, LOT #: 360490. AS THE PRODUCT HAS NOT BEEN RECEIVED, THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED; A REVIEW OF DEVICE HISTORY RECORDS AND COMPLAINT HISTORY. IN ADDITION, WE HAVE NOT BEEN PROVIDED WITH X-RAYS OR ANY SUPPORTING DOCUMENTATION WHICH COULD PROVIDE ADDITIONAL INFORMATION. A REVIEW OF THE MANUFACTURING HISTORY RECORDS CONFIRMS NO ABNORMALITIES OR DEVIATIONS REPORTED. A REVIEW OF THE COMPLAINT DATABASE OVER THE LAST 3 YEARS HAS FOUND NO SIMILAR COMPLAINTS REPORTED WITH THESE ITEMS. THE STERILE CERTIFICATE CONFIRM PRODUCT RECEIVED ADEQUATE AMOUNT OF RADIATIONS AND STERILIZED ACCORDING TO STANDARD SPECIFICATION. WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, ROOT CAUSE CANNOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN THE COMPLAINT WILL BE REOPENED AND INVESTIGATED THOROUGHLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT KNEE ARTHROPLASTY. SUBSEQUENTLY, AN IRRIGATION AND DEBRIDEMENT OF OXFORD PARTIAL KNEE WITH POLY REVISION WAS PERFORMED.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT. ASSOCIATED PRODUCTS: MEDICAL PRODUCT: OXF UNI TIB TRAY SZ AA RM PMA, CATALOG #: 159532, LOT #: 434130; MEDICAL PRODUCT: OXF TWIN-PEG CMNTD FEM XS PMA, CATALOG #: 161467, LOT #: 360490. 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 ARTHROPLASTY. SUBSEQUENTLY, AN IRRIGATION AND DEBRIDEMENT OF OXFORD PARTIAL KNEE WITH POLY REVISION WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848849 OXF ANAT BRG RT X-SM 3MM PMA UNICONDYLAR KNEE PROSTHESIS NRA BIOMET UK LTD. N/A 864580 05019279073016

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization