BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IBALANCE TKA TIBIAL TRAY SIZE 4

    MDR report key: 6250940 · Received January 13, 2017

    Report

    Report Number
    1220246-2016-00599
    Event Type
    Injury
    Date Received
    January 13, 2017
    Date of Event
    December 14, 2016
    Report Date
    January 25, 2017
    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. THIS IS A FOLLOW-UP SUBMISSION FOR DEVICE EVALUATION. 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-TTTE AND LOT NUMBER 913623, 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.

    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 DEVICE WAS NOT RETURNED FOR EVALUATION AND THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED. THE CATALOG NUMBER, AR-503-TTTE AND LOT NUMBER 913623, 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. DEVICE EXPECTED BUT NOT YET RETURNED.

    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 DUE TO TIBIAL LOOSENING. DURING THE REVISION PROCEDURE THE SURGEON EXPLANTED THE TIBIAL TRAY AR-503-TTTE LOT 913623 ((B)(4)), FEMORAL IMPLANT AR-503-PSLE LOT 108761324 ((B)(4)), BEARING IMPLANT AR-503-BE15 LOT 654425 ((B)(4)) AND PATELLA IMPLANT AR-504-PSC9 LOT 113601237 ((B)(4)). TO COMPLETE THE PROCEDURE THE SURGEON USED ANOTHER MANUFACTURER'S PRODUCT. PATIENT WAS A FEMALE, (B)(6). MEDICAL RECORDS DATED (B)(6) 2016 NOTED: EXAMINATION OF THE LEFT KNEE WITH PALPATION DEMONSTRATED INFERIOR POLE PATELLA AND MEDIAL TIBIAL PLATEAU TENDERNESS. MILD EFFUSION OF THE LEFT KNEE WAS NOTED. RANGE OF MOTION EXAMINATION OF THE LEFT KNEE DEMONSTRATED CREPITUS WITH MOTION. RECORDS NOTED THAT THE X-RAYS SHOWED PERIARTICULAR OSTEOPHYTES AND JOINT SPACE NARROWING. BONE SCAN WAS PERFORMED ON BOTH KNEES ON (B)(6) 2016: RESULTS STATED THERE WAS INCREASED UPTAKE INVOLVING BOTH KNEE REPLACEMENTS, THE LEFT SIDE MORE INCREASED THAN THE RIGHT. IT WAS ALSO NOTED THAT THIS MAY SUGGEST LOOSENING WHICH IS WORSE ON THE LEFT THAN THE RIGHT.

    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 DUE TO TIBIAL LOOSENING. DURING THE REVISION PROCEDURE THE SURGEON EXPLANTED THE TIBIAL TRAY AR-503-TTTE LOT 913623 ((B)(4)), FEMORAL IMPLANT AR-503-PSLE LOT 108761324 ((B)(4)), BEARING IMPLANT AR-503-BE15 LOT 654425 ((B)(4)) AND PATELLA IMPLANT AR-504-PSC9 LOT 113601237 ((B)(4)). TO COMPLETE THE PROCEDURE THE SURGEON USED ANOTHER MANUFACTURER'S PRODUCT. PATIENT WAS A FEMALE, (B)(6). MEDICAL RECORDS DATED (B)(6) 2016 NOTED: EXAMINATION OF THE LEFT KNEE WITH PALPATION DEMONSTRATED INFERIOR POLE PATELLA AND MEDIAL TIBIAL PLATEAU TENDERNESS. MILD EFFUSION OF THE LEFT KNEE WAS NOTED. RANGE OF MOTION EXAMINATION OF THE LEFT KNEE DEMONSTRATED CREPITUS WITH MOTION. RECORDS NOTED THAT THE X-RAYS SHOWED PERIARTICULAR OSTEOPHYTES AND JOINT SPACE NARROWING. BONE SCAN WAS PERFORMED ON BOTH KNEES ON 10/25/16: RESULTS STATED THERE WAS INCREASED UPTAKE INVOLVING BOTH KNEE REPLACEMENTS, THE LEFT SIDE MORE INCREASED THAN THE RIGHT. IT WAS ALSO NOTED THAT THIS MAY SUGGEST LOOSENING WHICH IS WORSE ON THE LEFT THAN THE RIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32776 IBALANCE TKA TIBIAL TRAY SIZE 4 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH ARTHREX, INC. 913623 00888867106710

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other AR-503-BE15, IBALANCE TKA BEARING, LOT 654425| AR-503PSLE, IBALANCE TKA FEMORAL, LOT 108761324| AR-504-PSC9, IBALANCE TKA PATELLA LOT 113601237