BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE TIBIAL INSERT

    MDR report key: 7649867 · Received June 29, 2018

    Report

    Report Number
    1818910-2018-63465
    Event Type
    Injury
    Date Received
    June 29, 2018
    Date of Event
    July 16, 2014
    Report Date
    June 6, 2018
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. 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

    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

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

    Description of Event or Problem · 1

    MEDICAL RECORDS RECEIVED ON 06/06/2018. MEDICAL RECORDS REVIEWED FOR MDR REPORTABILITY. LEFT ATTUNE TOTAL KNEE REVISED TO ADDRESS POSSIBLE INFECTION. PATIENT TREATED BY INCISION AND DRAINAGE, REPAIR OF PARTIAL WOUND DEHISCENCE, AND EXCHANGE OF POLYETHYLENE TIBIAL INSERT. THERE WAS EVIDENCE OF SYNOVITIS. THE MEDICAL RECORDS CURRENTLY PROVIDE NO PRIMARY SURGERY INFORMATION OR PRODUCT LOT CODE INFORMATION. CEMENT MANUFACTURER FOR THE PRIMARY SURGERY IS ALSO UNKNOWN. AN ATTUNE INSERT WAS RE-IMPLANTED AT THE TIME OF REVISION, SUPPORTING THE ALLEGATION OF AN ATTUNE KNEE BEING PRESENT. DOI: UNKNOWN; DOR: (B)(6) 2014; (LEFT KNEE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493515 UNKNOWN KNEE TIBIAL INSERT KNEE TIBIAL INSERT JWH DEPUY IRELAND - 9616671

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention