BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA STAB XLK INS 4 12.5MM

    MDR report key: 7227113 · Received January 30, 2018

    Report

    Report Number
    1818910-2018-52304
    Event Type
    Injury
    Date Received
    January 30, 2018
    Date of Event
    January 9, 2018
    Report Date
    January 9, 2018
    Manufacturer
    DEPUY ORTHOPAEDICS INC 1818910
    Product Code
    JWH
    UDI-DI
    10603295064503
    PMA / PMN Number
    K040166
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (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 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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS INFECTION. THE SURGEON DID AN I&D WITH A POY EXCHANGE. DOI: UNKNOWN; DOR: (B)(6) 2018; RIGHT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71358 SIGMA STAB XLK INS 4 12.5MM SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT JWH DEPUY ORTHOPAEDICS INC 1818910 UNKNOWN 10603295064503

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention