BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIG FEM ADAP +2/-2 OFFSET BOLT

    MDR report key: 4483291 · Received February 4, 2015

    Report

    Report Number
    1818910-2015-12577
    Event Type
    Injury
    Date Received
    February 4, 2015
    Date of Event
    January 14, 2015
    Report Date
    January 14, 2015
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK060515
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4). FOLLOW-UP WITH THE COMPLAINANT HAS BEEN CONDUCTED FOR THE LOT NUMBER AND THIS INFORMATION IS NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED INSTRUMENT CONFIRMED THE BLACK PLASTIC PROTECTOR COMPONENT HAS CRACKED AND BECOME DISASSEMBLED FROM THE WRENCH. CAPA (B)(4) WAS INITIATED TO FURTHER INVESTIGATE AND DETERMINE ROOT CAUSE AND CORRECTIVE ACTIONS. CO (B)(4) HAS BEEN INITIATED TO CHANGE THEN DESIGN OF PRODUCT CODE 961673 AS PART OF CAPA (B)(4). THE CURRENT COMPLAINT SAMPLE WAS MANUFACTURED PRIOR TO THE IMPLEMENTATION OF CO (B)(4). NO FURTHER CORRECTIVE ACTION REQUIRED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    PATIENT HAD A SIGMA TC3 REVISION PERFORMED. DOCTOR USED A +2MM OFFSET ON THE FEMUR. HOWEVER, WHEN REAL +2MM ADAPTER BOLT WAS ASSEMBLED THE TORQUE WRENCH GOT STUCK ON THE FEMUR AS THE GASKET ON THE WRENCH BROKE AND HAD TO BE HAMMERED OFF. AFTER OFFSET BOLT WAS PUT TOGETHER, IT APPEARED AS IF THE MARKINGS ON THE TC3 FEMUR BOX SHOWED THAT THE BOLT WAS PUT IN THE -2MM POSITION EVEN THOUGH THE ARROW OF THE BOLT WAS POINTING TOWARDS THE FLANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81639 SIG FEM ADAP +2/-2 OFFSET BOLT KNEE OTHER IMPLANT JWH DEPUY ORTHOPAEDICS, INC. 599417

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR