BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IBALANCE TKA TIBIAL TRAY SIZE 2

    MDR report key: 5822774 · Received July 26, 2016

    Report

    Report Number
    1220246-2016-00299
    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
    UDI-DI
    00888867106703
    PMA / PMN Number
    K081127
    Removal / Correction Number
    1220246-1/29/16-001-R.
    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 FIRST OF TWO SUBMISSIONS FROM THE SAME PATIENT EVENT. THE OTHER IS 1220246-2016-00300 ((B)(4)). 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-TTTC AND LOT NUMBER 982771 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, 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, (B)(6). 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
    474769 IBALANCE TKA TIBIAL TRAY SIZE 2 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH ARTHREX, INC. 982771 00888867106703

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other| R