BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXF UNI TIB TRAY SZ D

    MDR report key: 7358784 · Received March 21, 2018

    Report

    Report Number
    3002806535-2018-00530
    Event Type
    Injury
    Date Received
    March 21, 2018
    Date of Event
    November 4, 2015
    Report Date
    March 20, 2018
    Manufacturer
    BIOMET UK LTD.
    Product Code
    NRA
    PMA / PMN Number
    PP010014
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCT(S): A 161470, OXF TWIN-PEG CMNTD FEM LG PMA, 317380; 159583, OXF ANAT BRG RT LG SIZE 4 PMA, 087060. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. THE PRODUCT WAS NOT RETURNED FOR THE INVESTIGATION, THEREFORE A VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORT EVENT WAS NOT REPORTED. 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. THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535 - 2018 - 00531, 3002806535 - 2018 - 00532.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT RIGHT KNEE SURGERY. SUBSEQUENTLY, POST-OPERATIVE PAIN AND OTHER EXPERIENCES WERE REPORTED AT THE FOLLOW-UP VISITS: SOME PROBLEMS WALKING, UNABLE TO PERFORM USUAL ACTIVITIES, PAIN IN BED MOST NIGHTS, DIFFICULTY PERFORMING USUAL WORK, MODERATE DIFFICULTY GOING DOWN STAIRS, LIMPING, AND MODERATE DIFFICULTY KNEELING. AT THE 1-YEAR FOLLOW-UP, THE COMPLICATION, ASSISTIVE DEVICE EFFECT: PATELLA TENDONITIS, WAS REPORTED. AT THIS TIME THERE IS NO INDICATION OF SURGICAL DELAYS OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201575 OXF UNI TIB TRAY SZ D PROSTHESIS, KNEE NRA BIOMET UK LTD. N/A 317560

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other