BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IBALANCE TKA TIBIAL TRAY, SIZE 7

    MDR report key: 5911765 · Received August 29, 2016

    Report

    Report Number
    1220246-2016-00357
    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
    UDI-DI
    00888867106758
    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 REVEALED THAT THE RETURNED DEVICE'S CRITICAL MATING FEATURES ON SURFACE A (SURFACE THAT MATES WITH THE BEARING) ARE WITHIN SPECIFICATION. THE DAMAGES OBSERVED ON THE SURFACES WERE MOST LIKELY CAUSED DURING THE EXTRACTION OF THE IMPLANT. THE CATALOG NUMBER, AR-503-TTTH AND LOT NUMBER 984546 ASSOCIATED WITH THIS EVENT HAS BEEN INVOLVED IN RECALL NUMBER 1220246-1/29/16-001-R. THE INFORMATION RECEIVED REGARDING THE EVENT IS NOT SUFFICIENT TO DETERMINE THE CAUSE OF THE EVENT OR WHETHER IT HAD ANY RELATION TO THE RECALL.

    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)(4)), FEMORAL IMPLANT AR-503-PSLH (LOT 108761213) ((B)(4)), AND BEARING IMPLANT AR-503-BH12 (LOT 77941245) ((B)(4)). TO COMPLETE THE PROCEDURE THE SURGEON USED ANOTHER MANUFACTURER'S PRODUCT. PATIENT WAS A MALE, DOB (B)(6). 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
    562572 IBALANCE TKA TIBIAL TRAY, SIZE 7 PROTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/ JWH ARTHREX, INC. 984546 00888867106758

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other