BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE IMPLANT

    MDR report key: 8479845 · Received April 3, 2019

    Report

    Report Number
    1818910-2019-89609
    Event Type
    Injury
    Date Received
    April 3, 2019
    Date of Event
    March 13, 2019
    Report Date
    March 13, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 181891
    Product Code
    JWH
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. BRAND NAME, COMMON DEVICE NAME, PROCODE, LOT #, PART #, UDI #, 510K: THIS REPORT IS FOR AN UNKNOWN DEVICE/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY ==> NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. 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, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    PATIENT WAS REVISED DUE TO INFECTION. DOI: UNKNOWN; DOR: (B)(6) 2019; RIGHT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271435 UNKNOWN KNEE IMPLANT KNEE IMPLANT JWH DEPUY ORTHOPAEDICS, INC. 181891 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention