BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IBALANCE TKA FEMORAL IMPLANT

    MDR report key: 5822776 · Received July 26, 2016

    Report

    Report Number
    1220246-2016-00300
    Event Type
    Injury
    Date Received
    July 26, 2016
    Date of Event
    June 27, 2016
    Report Date
    July 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. THIS IS THE SECOND OF TWO SUBMISSIONS FROM THE SAME PATIENT EVENT. THE OTHER IS 1220246-2016-00299 (LINE 165453). THE EVALUATION REVEALED EXTENSIVE DAMAGES AND DISRUPTED SURFACE FINISH ON THE RETURNED DEVICE. 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. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON 2640128-2012-00063 2014, PATIENT UNDERWENT A RIGHT TKA PROCEDURE DURING WHICH TIME THE PATELLA WAS NOT RESURFACED. ON (B)(6) 2016, THE SURGEON PERFORMED A REVISION RIGHT TKA PROCEDURE DUE TO LOOSE TIBIA AND FEMUR. DURING THE REVISION PROCEDURE THE SURGEON EXPLANTED THE TIBIAL TRAY AR-503-TTTC (LOT 982771), FEMORAL IMPLANT AR-503-PSRC (LOT 108761219) AND BEARING IMPLANT AR-503-BC10 (LOT 113601232). PATIENT, FEMALE, DOB (B)(6) 1953. THE FOLLOWING ARTHREX PRODUCTS WERE IMPLANTED DURING THE REVISION: TIBIAL TRAY AR-513-T1 (LOT 10018251), FEMORAL IMPLANT AR-516-1R (LOT 1355279), BEARING IMPLANT AR-513-BB16 (LOT 113601513), PATELLA IMPLANT AR-504-PSB8 (LOT 113601447) AND STEM EXTENSION IMPLANT AR-513-1050 (LOT 10018102). PATIENT MEDICAL RECORDS OF (B)(6) 2016 NOTED PATIENT REPORTED CHRONIC ANTERIOR KNEE PAIN, KNEE SWELLING WITH ACTIVITY, STAIRS ARE DIFFICULT AND EPISODES OF INSTABILITY OF KNEE. NO REPORT AT THAT TIME OF PAIN IN PLATEAU. EXAMINATION OF RIGHT KNEE DEMONSTRATED SWELLING. PALPATION OF THE RIGHT KNEE DEMONSTRATED INFERIOR PATELLAR POLE TENDERNESS BUT NO MEDIAL TIBIAL PLATEAU OR LATERAL TIBIAL PLATEAU TENDERNESS. MODERATE EFFUSION OF RIGHT KNEE, MODERATE CREPITUS WITH MOTION AND PAIN WITH FLEXION BUT NOT WITH EXTENSION WERE NOTED. RECORDS ALSO NOTED A POSITIVE GRIND TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475548 IBALANCE TKA FEMORAL IMPLANT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH ARTHREX, INC. 108761219

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other| R