BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIG MOD TIB TRAY CEM COCR 2.5

    MDR report key: 3873642 · Received June 16, 2014

    Report

    Report Number
    1818910-2014-21020
    Event Type
    Injury
    Date Received
    June 16, 2014
    Date of Event
    August 1, 2012
    Report Date
    June 17, 2014
    Manufacturer
    DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS1219655
    Product Code
    JWH
    PMA / PMN Number
    PK032151
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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.

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A. PATIENT MEDICAL RECORDS WERE PROVIDED AND REVIEWED. REVIEW OF THE RECORDS CONFIRMED LOOSENING OF THE TIBIAL COMPONENT AND OSTEOLYSIS. WITHIN THE INDICATIONS PORTION THE SURGEON NOTES THE PATIENT IS MORBIDLY OBESE, WAS REVISED 9 YEARS PRIOR AND HAD THE SAME FAILURE ON THE LEFT. FROM A MEDICAL PERSPECTIVE, BASED ON THE INFORMATION AVAILABLE, THE COMPLAINT IS NOT PRODUCT RELATED. IFU'S CAUTION SURGEONS IN THAT OBESITY TENDS TO IMPOSE SEVERE LOADING ON THE AFFECTED EXTREMITY PLACING THE PATIENT AT HIGHER RISK OF FAILURE. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION. 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

    CLINICAL STATES MIGRATION, TIBIAL LOOSENING. THE INTERFACE AND CEMENT MANUFACTURER ARE UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352138 SIG MOD TIB TRAY CEM COCR 2.5 KNEE TIBIAL TRAY JWH DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS1219655 ZD4N74000

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention