BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IBALANCE TKA TIBIAL TRAY, SIZE 3

    MDR report key: 6015411 · Received October 10, 2016

    Report

    Report Number
    1220246-2016-00412
    Event Type
    Injury
    Date Received
    October 10, 2016
    Date of Event
    September 14, 2016
    Report Date
    September 14, 2016
    Manufacturer
    ARTHREX, INC.
    Product Code
    JWH
    UDI-DI
    00888867106710
    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. 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-TTTD AND LOT NUMBER 1297049, 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) 2015 A PATIENT UNDERWENT A LEFT TKA PROCEDURE. ON (B)(6) 2016 THE SURGEON PERFORMED A REVISION LEFT TKA DUE TO TIBIAL LOOSENING. DURING THE REVISION PROCEDURE THE SURGEON EXPLANTED THE TIBIAL TRAY AR-503-TTTD LOT 1297049 ((B)(4)) AND BEARING IMPLANT AR-513-BD08 LOT 113601337 ((B)(4)). TO COMPLETE THE PROCEDURE THE SURGEON IMPLANTED THE FOLLOWING ARTHREX PRODUCTS: TIBIAL TRAY AR-513-T4 LOT 10038080, BEARING IMPLANT AR-513-BE13 LOT 113601339A AND STEM EXTENSION IMPLANT AR-513-1450 LOT 1002348. PATIENT WAS A FEMALE, (B)(6). PATIENT MEDICAL RECORDS DATED (B)(6) 2016 NOTED PATIENT HAS A FALL IN (B)(6) 2016. AFTER FALL PATIENT WAS TREATED WITH KNEE ASPIRATION AND INJECTION. PATIENT WAS TREATED FOR CONTUSION. IT WAS FURTHER NOTED THAT PATIENT CONTINUES TO HAVE RECURRENT SWELLING IN HER KNEE AND POSTERIOR MEDIAL PAIN WITH SNAPPING SENSATION. MEDICAL RECORDS NOTED PATIENT WAS FINE UNTIL THE FALL. EXAMINATION OF THE LEFT KNEE DEMONSTRATED SWELLING BUT NO ERYTHEMA OR ECCHYMOSIS. PALPATION OF LEFT KNEE DEMONSTRATED MEDIAL JOINT LINE TENDERNESS BUT NO LATERAL JOINT LINE TENDERNESS. MILD EFFUSION OF THE LEFT KNEE WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665766 IBALANCE TKA TIBIAL TRAY, SIZE 3 PROTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/ JWH ARTHREX, INC. 1297049 00888867106710

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other AR-513-BD08, IBALANCE TKA BEARING, LOT 113601337