BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSERT, TIBIAL, S #2 MJS KNEE

    MDR report key: 16587678 · Received March 21, 2023

    Report

    Report Number
    1644408-2023-00305
    Event Type
    Injury
    Date Received
    March 21, 2023
    Date of Event
    February 23, 2023
    Report Date
    March 21, 2023
    Manufacturer
    ENCORE MEDICAL L.P
    Product Code
    OIY
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REASON FOR THIS REVISION SURGERY, IT WAS REPORTED AS, REVISION SURGERY: "THE REASON FOR THIS REVISION IS POLY WEAR. MALE 74 YRS" THE ACTUAL LENGTH OF IN-VIVO FOR THE ITEM(S) LISTED IS UNKNOWN AS THE ORIGINAL SURGERY DATE WAS NOT PROVIDED OR COULD BE ESTABLISHED. THIS INVESTIGATION IS LIMITED IN SCOPE AS ONLY PARTIAL INFORMATION WAS PROVIDED TO DJO SURGICAL - AUSTIN FOR REVIEW. THE REVISED ITEM(S) WAS NOT RETURNED FOR EXAMINATION AND THE ITEM AND OR LOT NUMBER(S) WAS NOT PROVIDED. TO ADEQUATELY INVESTIGATE THIS EVENT, THE PART AND LOT NUMBER(S) ARE NECESSARY. IF THIS INFORMATION IS SUBMITTED AT A FUTURE DATE, THIS INVESTIGATION WILL BE RE-EVALUATED. CUSTOMER COMPLAINT HISTORY OF THE REPORTED ITEM(S) SHOWED NO PRESENT TRENDS OR ON-GOING ISSUES THAT ARE NEEDING A REVIEW. THERE WAS NO INFORMATION SUBMITTED WITH THIS COMPLAINT ABOUT ANY PATIENT ACTIVITIES, ACCIDENTS, OR MEDICAL CONTRAINDICATIONS THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THE SURGEON PERFORMED THIS REVISION TO REMEDY THE PATIENT'S CONDITION. THIS COMPLAINT WILL BE CLOSED PENDING RECEIPT OF ADDITIONAL INFORMATION. NO FURTHER ACTION IS DEEMED NECESSARY AT THIS TIME.

    Description of Event or Problem · 0

    REVISION SURGERY - DUE TO POLY WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12819 INSERT, TIBIAL, S #2 MJS KNEE PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL OIY ENCORE MEDICAL L.P UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Required Intervention 77-0001-5B LOT: UNKNOWN