BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF ANAT BRG RT LG SIZE 4 PMA

    MDR report key: 9863704 · Received March 22, 2020

    Report

    Report Number
    3002806535-2020-00173
    Event Type
    Injury
    Date Received
    March 22, 2020
    Date of Event
    February 24, 2020
    Report Date
    April 30, 2020
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    UDI-DI
    05019279786299
    PMA / PMN Number
    P010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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 THE ITEM. 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 RIGHT INITIAL KNEE ARTHROPLASTY. SUBSEQUENTLY, A REVISION PROCEDURE DUE TO LOOSENING WAS PERFORMED.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. MEDICAL PRODUCT: OXF UNI TIB TRAY SZ C RM PMA, CATALOG #: 154723, LOT #: 140550; MEDICAL PRODUCT: OXF TWIN-PEG CMNTD FEM LG PMA, CATALOG #: 161470, LOT #: 914900. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT RIGHT INITIAL KNEE ARTHROPLASTY. SUBSEQUENTLY, A REVISION PROCEDURE DUE TO LOOSENING WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327397 OXF ANAT BRG RT LG SIZE 4 PMA UNICONDYLAR KNEE PROSTHESIS NRA BIOMET UK LTD. N/A 313640 05019279786299

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R