BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IBALANCE TKA TIBIAL TRAY SIZE 8

    MDR report key: 5849925 · Received August 5, 2016

    Report

    Report Number
    1220246-2016-00318
    Event Type
    Injury
    Date Received
    August 5, 2016
    Date of Event
    July 11, 2016
    Report Date
    August 24, 2016
    Manufacturer
    ARTHREX, INC.
    Product Code
    JWH
    UDI-DI
    00888867106765
    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 CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED. THE CATALOG NUMBER, AR-503-TTTJ AND LOT NUMBER 1191341, 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. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    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-TTTJ AND LOT NUMBER 1191341 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. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. DEVICE BEING RETURNED. NOT YET RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2015, PATIENT UNDERWENT A RIGHT TKA PROCEDURE. ON (B)(6) 2016 SURGEON PERFORMED A REVISION RIGHT TKA DUE TO TIBIAL LOOSENING. DURING THE REVISION PROCEDURE THE SURGEON EXPLANTED THE TIBIAL TRAY AR-503-TTTJ (LOT 1191341)((B)(4)), AND BEARING IMPLANT AR-513-BJ14 (LOT 113601408)((B)(4)). TO COMPLETE THE PROCEDURE THE SURGEON IMPLANTED THE FOLLOWING ARTHREX PARTS: TIBIAL TRAY AR-513-T8 (LOT 10019689), BEARING IMPLANT AR-513-BJ20 (LOT 113601407) AND STEM EXTENSION IMPLANT AR-513-1450 (LOT 10024348). PATIENT WAS A MALE, (B)(6), DOB (B)(6). DURING THE REVISION THE SURGEON WAS USING A AR-613-1 ((B)(4)), UNIVERSAL HANDLE, LOT 1391544 FOR THE REMOVAL OF THE TIBIAL PUNCH HEAD. THE PUNCH HEAD WAS ABLE TO BE REMOVED BUT THE HANDLE BROKE IN THE PROCESS. ALSO BEING USED WAS AN AR-623-3 ((B)(4)), IBALANCE TKA T2 TORQUE DRIVER, LOT 221522. THE DEVICE WAS USED TO COMPLETE THE TIGHTENING OF THE STEM EXTENSION LOCKING SCREW BUT IN THE PROCESS THE DEVICE TIP BROKE. ALL BROKEN PIECES FULLY RETRIEVED. BROKEN DEVICES ARE BEING RETURNED FOR EVALUATION. PATIENT MEDICAL RECORDS DATED (B)(6) 2016 NOTED PATIENT HAD BEEN DOING WELL UNTIL 1 1/2 WEEKS PRIOR TO VISIT. AT THAT TIME PATIENT BEGAN HAVING ANTERIOR KNEE PAIN WITHOUT PRECIPITATING INJURY. PATIENT HAD MODERATE EFFUSION AND SELLING WITHOUT EVIDENCE OF INFECTION OR ERYTHEMA. PATIENT WAS ASPIRATED AND FLUID SENT FOR STUDIES. RESULTS WERE NEGATIVE FOR INFECTION. PATIENT (B)(6) 2016 FOLLOW UP VISIT RECORDS NOTED PATIENT CONTINUED TO HAVE PAIN AND SWELLING. PALPATION OF THE RIGHT KNEE DEMONSTRATED MEDIAL TIBIAL PLATEAU TENDERNESS BUT NO MEDIAL JOINT LINE OR LATERAL JOINT LINE TENDERNESS. MILD EFFUSION OF THE RIGHT KNEE WAS NOTED. SURGEON RECOMMENDED TOTAL KNEE REPLACEMENT DUE TO PAIN IN THE KNEE THAT WAS INCREASED WITH ACTIVITY AND WEIGHTBEARING. PATIENT HAD PAIN THROUGH A LIMITED PASSIVE RANGE OF MOTION WITH CREPITUS AND SWELLING. RECORDS ALSO NOTED THAT X-RAYS SHOWED PERIARTICULAR OSTEOPHYTES AND JOINT SPACE NARROWING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2015, PATIENT UNDERWENT A RIGHT TKA PROCEDURE. ON (B)(6) 2016 SURGEON PERFORMED A REVISION RIGHT TKA DUE TO TIBIAL LOOSENING. DURING THE REVISION PROCEDURE, THE SURGEON EXPLANTED THE TIBIAL TRAY AR-503-TTTJ (LOT 1191341)((B)(6)), AND BEARING IMPLANT AR-513-BJ14 (LOT 113601408)((B)(6)). TO COMPLETE THE PROCEDURE THE SURGEON IMPLANTED THE FOLLOWING ARTHREX PARTS: TIBIAL TRAY AR-513-T8 (LOT 10019689), BEARING IMPLANT AR-513-BJ20 (LOT 113601407) AND STEM EXTENSION IMPLANT AR-513-1450 (LOT 10024348). PATIENT WAS A MALE, AGE (B)(6). DURING THE REVISION THE SURGEON WAS USING A AR-613-1 ((B)(6)), UNIVERSAL HANDLE, LOT 1391544 FOR THE REMOVAL OF THE TIBIAL PUNCH HEAD. THE PUNCH HEAD WAS ABLE TO BE REMOVED BUT THE HANDLE BROKE IN THE PROCESS. ALSO BEING USED WAS AN AR-623-3 ((B)(6)), IBALANCE TKA T2 TORQUE DRIVER, LOT 221522. THE DEVICE WAS USED TO COMPLETE THE TIGHTENING OF THE STEM EXTENSION LOCKING SCREW BUT IN THE PROCESS THE DEVICE TIP BROKE. ALL BROKEN PIECES FULLY RETRIEVED. BROKEN DEVICES ARE BEING RETURNED FOR EVALUATION. PATIENT MEDICAL RECORDS DATED (B)(6) 2016 NOTED PATIENT HAD BEEN DOING WELL UNTIL 1 1/2 WEEKS PRIOR TO VISIT. AT THAT TIME, PATIENT BEGAN HAVING ANTERIOR KNEE PAIN WITHOUT PRECIPITATING INJURY. PATIENT HAD MODERATE EFFUSION AND SELLING WITHOUT EVIDENCE OF INFECTION OR ERYTHEMA. PATIENT WAS ASPIRATED AND FLUID SENT FOR STUDIES. RESULTS WERE NEGATIVE FOR INFECTION. PATIENT (B)(6) 2016 FOLLOW UP VISIT RECORDS NOTED PATIENT CONTINUED TO HAVE PAIN AND SWELLING. PALPATION OF THE RIGHT KNEE DEMONSTRATED MEDIAL TIBIAL PLATEAU TENDERNESS BUT NO MEDIAL JOINT LINE OR LATERAL JOINT LINE TENDERNESS. MILD EFFUSION OF THE RIGHT KNEE WAS NOTED. SURGEON RECOMMENDED TOTAL KNEE REPLACEMENT DUE TO PAIN IN THE KNEE THAT WAS INCREASED WITH ACTIVITY AND WEIGHTBEARING. PATIENT HAD PAIN THROUGH A LIMITED PASSIVE RANGE OF MOTION WITH CREPITUS AND SWELLING. RECORDS ALSO NOTED THAT X-RAYS SHOWED PERIARTICULAR OSTEOPHYTES AND JOINT SPACE NARROWING. PATIENT WAS SCHEDULED FOR A RIGHT KNEE REVISION BEARING EXCHANGE, POSSIBLE FULL REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502926 IBALANCE TKA TIBIAL TRAY SIZE 8 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH ARTHREX, INC. 1191341 00888867106765

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other| R AR-613-1, IBAL. KEEL PUNCH, LOT 1391544