BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTUNE RP TIB BASE SZ 5 CEM

    MDR report key: 7269768 · Received February 14, 2018

    Report

    Report Number
    1818910-2018-53328
    Event Type
    Injury
    Date Received
    February 14, 2018
    Date of Event
    January 29, 2018
    Report Date
    January 30, 2018
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    NJL
    PMA / PMN Number
    P830055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH , A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    PATIENT REPORTED SUBSEQUENT TO A FALL WITH PAINFUL AND UNSTABLE ATTUNE RP PS TKA WITH APPARENT MEDICALLY SUBSIDED TIBIAL COMPONENT AND LATERALLY SUBLUXED PATELLA COMPONENT. ORIGINAL SURGERY (B)(6) 2017. PATIENT CONSEQUENCE? :YES. PATIENT CONSEQUENCE DESCRIPTION:RETAINED HARDWARE REVISION SURGERY. ACTION TAKEN FOR PROCEDURE:RETAINED ATTUNE PRIMARY PS FEMUR AND REVISED ATTUNE PRIMARY RP TIBIAL TRAY TO A SIZE 4 ATTUNE REVISION FB TRAY, 14X130 CEMENTED STEM AND 16MM ATTUNE PS FB INSERT RESULTING IN A STABLE CONSTRUCT. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112580 ATTUNE RP TIB BASE SZ 5 CEM KNEE TIBIAL TRAY NJL DEPUY IRELAND - 9616671 8508878

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention