BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA FEM ADAPTER 7 DEGREE

    MDR report key: 3893583 · Received June 25, 2014

    Report

    Report Number
    1818910-2014-21917
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 5, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK060515
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES ON THE PROVIDED PRODUCT/LOT COMBINATION. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A. NO ADDITIONAL INFORMATION WAS OBTAINED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. 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

    PROCEDURE: KNEE REVISION (NON-DEPUY). UPON ASSEMBLING DEFINITIVE IMPLANTS, SURGEON NEEDED TO BREAK TAPER TO RESET IMPLANT POSITION. SURGEON WAS UNABLE TO DISENGAGE THE TAPER BETWEEN SLEEVE AND 7 DEGREES FEMORAL ADAPTOR, TO WHICH CONSTANT ATTEMPTS RESULTED IN ADAPTOR BREAKING. WHEN NEW ADAPTOR ARRIVED, IMPLANTS WERE REASSEMBLED AND PROCEDURE PROGRESSED AS NORMAL. PFC SIGMA TIBIAL STEM EXTENSION (REF: (B)(4) LOT EH6NR4) WAS ALSO USED IN CONJUNCTION WITH THE FEMORAL ADAPTOR AND THE FEMORAL SLEEVE. THERE WAS NO ISSUE NOTED ON THE TIBIAL STEM EXTENSION BUT THE SURGEON DECIDED NOT TO RE-USE THIS AND REPLACED IMPLANT WITH A NEW ONE. PROCEDURE WAS DELAYED BY 75 MINUTES WHILE SURGEON WAITED FOR REPLACEMENT IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369905 SIGMA FEM ADAPTER 7 DEGREE KNEE OTHER IMPLANT JWH DEPUY ORTHOPAEDICS, INC. 433808

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other