BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC*SIGMA C/S NPOR FEM LT SZ 3

    MDR report key: 3874559 · Received June 16, 2014

    Report

    Report Number
    1818910-2014-21050
    Event Type
    Injury
    Date Received
    June 16, 2014
    Date of Event
    January 14, 2014
    Report Date
    May 22, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK950010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS. PREVIOUS REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A. NO ADDITIONAL INFORMATION WAS OBTAINED. A PREVIOUS REVIEW OF THE SUPPLIED MEDICAL RECORDS CONFIRMED LOOSENING OF THE TIBIAL TRAY. 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.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING. 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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS TIBIAL LOOSENING AT THE CEMENT/IMPLANT INTERFACE. DEPUY CEMENT WAS USED. UPDATE RECV'D (B)(6) 2014 - PATIENT'S REVISION OPERATIVE RECORDS WERE RECEIVED. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING MDR DECISION. THIS COMPLAINT WAS UPDATED (B)(6) 2014 UPDATE REC'D (B)(6) 2014- CLINICAL REPORT RECEIVED- GROUP: DOTS. PATIENT WAS REVISED BECAUSE OF A "VALGUS SHIFT OF FEMORAL AND TIBIAL COMPONENT CONSISTENT OF LOOSENING." LOOSENING OCCURRED AT THE BONE/CEMENT AND CEMENT/IMPLANT INTERFACES. CEMENT WAS DEPUY MANUFACTURED 06/16/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352471 PFC*SIGMA C/S NPOR FEM LT SZ 3 KNEE FEMORAL COMPONENT JWH DEPUY ORTHOPAEDICS, INC. 307043CA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention