BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNATOMIC VF TIB CLIP

    MDR report key: 9569255 · Received January 9, 2020

    Report

    Report Number
    1818910-2020-01239
    Event Type
    Injury
    Date Received
    January 9, 2020
    Date of Event
    January 1, 2019
    Report Date
    September 2, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KYK
    UDI-DI
    10603295008354
    PMA / PMN Number
    K851341
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE(S) WAS NOT PROVIDED. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. CORRECTIVE ACTION WAS NOT INDICATED. (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

    PLANNED REVISION TKR ON (B)(6) 2019 FOR A SAS. REVISION WAS PERFORMED DUE TO ANTERIOR KNEE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30386 SYNATOMIC VF TIB CLIP KNEE TIBIAL INSERT ACCESSORY KYK DEPUY ORTHOPAEDICS INC US 10603295008354

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention