BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC*SIGMA TC3 FEM LEFT SZ3

    MDR report key: 3231403 · Received July 17, 2013

    Report

    Report Number
    1818910-2013-21430
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    July 10, 2013
    Report Date
    July 10, 2013
    Manufacturer
    9616671 DEPUY (IRELAND)
    Product Code
    JWH
    PMA / PMN Number
    PK952830
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES WERE RETURNED FOR REVIEW. THE X-RAYS SUBMITTED DISPLAY MULTIPLE PROCEDURES THAT HAD BEEN PERFORMED ON THE KNEE PRIOR TO THE SIGMA TC3, INCLUDING AN ANTIBIOTIC SPACER. THE M/L VIEW INCLUDING THE ANTIBIOTIC SPACER SHOWS A DARKER AREA AT THE DISTAL FEMUR WHICH MAY INDICATE LOWER BONE DENSITY IN THIS AREA. THE IMAGE SHOWN SEQUENTIALLY AFTER THE ANTIBIOTIC SPACER INCLUDES THE TC3 FEMORAL IMPLANT. THIS IMAGE SHOWS A LATERAL JOINT SPACE GAP THAT IS MUCH GREATER THAN THE MEDIAL JOINT SPACE, WHICH MAY INDICATE LATERAL SOFT TISSUE LAXITY. DATES FOR INDIVIDUAL IMAGES ARE NOT PROVIDED, SO ACTUAL SURGICAL SEQUENCE CANNOT BE CONFIRMED WITH THESE IMAGES. THE PATIENT MAY HAVE A BMI HIGHER THAN TYPICAL. NO INFORMATION SUCH AS OPERATIVE NOTES HAS BEEN PROVIDED WHICH CONFIRMS THAT THE STEM BOLT WAS ASSEMBLED TO THE FEMUR PER THE SURGICAL TECHNIQUE. THE RETURNED FEMORAL COMPONENT DISPLAYS BURNISHING ON THE SUPERIOR FACE OF THE BOX, WHICH MAY HAVE BEEN A RESULT OF MOTION WITH RESPECT TO THE MODULAR INTRAMEDULLARY STEM. AS RETURNED, THE CEMENT WHICH REMAINED ATTACHED TO THE FEMORAL COMPONENT SHOWS VERY LITTLE ¿IMPRESSION¿ OF CORTICAL BONE. AMOUNT OF BONE CEMENT ATTACHED TO FEMUR ON SUPERIOR SURFACES ON BOTH SIDES OF FEMORAL BOX MAY INDICATE SIGNIFICANT DISTAL FEMORAL BONE LOSS. THE LAST FOUR X-RAY IMAGES IN THE SEQUENCE SHOW INDICATION THAT THE STEM HAS LOOSENED FROM THE FEMORAL COMPONENT AND THAT THE STEM BOLT AND STEM COLLAR ARE LOOSE IN THE JOINT. THE CAUSE OF THE STEM LOOSENING FROM THE FEMUR CANNOT BE DEFINITIVELY DETERMINED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. THE INVESTIGATION CAN DRAW NO CONCLUSION WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    REVISION OF TC3 KNEE REPLACEMENT DUE TO FEELING OF INSTABILITY IN KNEE AND PRESENTATION OF LOOSE STEM BOLT IN JOINT SAPCE ON XRAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331208 PFC*SIGMA TC3 FEM LEFT SZ3 FEMORAL PROTHESIS JWH 9616671 DEPUY (IRELAND) C2SMG4

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention