BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IBAL TKA FEM,PS SZ 7,LFT,CEMENTED

    MDR report key: 5912011 · Received August 29, 2016

    Report

    Report Number
    1220246-2016-00358
    Event Type
    Injury
    Date Received
    August 29, 2016
    Date of Event
    August 1, 2016
    Report Date
    August 1, 2016
    Manufacturer
    ARTHREX, INC.
    Product Code
    JWH
    PMA / PMN Number
    K081127
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO ARTHREX'S FOLLOW-UP REQUESTS. THE EVALUATION OF THE RETURNED DEVICE REVEALED EXTENSIVE DAMAGES AND DISRUPTED SURFACE FINISH. THE DAMAGES OBSERVED WERE MOST LIKELY CAUSED DURING THE EXTRACTION OF THE IMPLANT. AT THE CURRENT TIME THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2014, A PATIENT UNDERWENT A LEFT TKA PROCEDURE. ON (B)(6) 2016, THE SURGEON PERFORMED A REVISION LEFT TKA REPORTEDLY DUE TO LOOSE FEMUR AND TIBIA. DURING THE REVISION PROCEDURE THE SURGEON EXPLANTED THE TIBIAL TRAY AR-503-TTTH (LOT 984546 ) ((B)(6)), FEMORAL IMPLANT AR-503-PSLH (LOT 108761213) ((B)(6)), AND BEARING IMPLANT AR-503-BH12 (LOT 77941245) ((B)(6)). TO COMPLETE THE PROCEDURE THE SURGEON USED ANOTHER MANUFACTURER'S PRODUCT. PATIENT WAS A MALE, DOB (B)(6) 1962. PATIENT MEDICAL RECORDS DATED (B)(6) 2016 NOTED PATIENT CONTINUES TO HAVE INCREASED PAIN. EXAMINATION OF THE LEFT KNEE WITH PALPATION DEMONSTRATES MEDIAL JOINT LINE TENDERNESS AND PATELLOFEMORAL REGION TENDERNESS BUT NO LATERAL JOINT LINE TENDERNESS. MILD EFFUSION OF THE LEFT KNEE NOTED. KNEE DEMONSTRATED MILD RETROPATELLAR CREPITUS WITH MOTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562557 IBAL TKA FEM,PS SZ 7,LFT,CEMENTED PROTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/ JWH ARTHREX, INC. 108761213

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other AR-503-BH12, IBALANCE TKA BEARING, LOT 77941245