BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC*SIGMA C/S NPOR FE LT SZ2.5

    MDR report key: 4073001 · Received September 9, 2014

    Report

    Report Number
    1818910-2014-27562
    Event Type
    Injury
    Date Received
    September 9, 2014
    Date of Event
    August 11, 2014
    Report Date
    August 11, 2014
    Manufacturer
    DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS 121965
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A. NO ADDITIONAL INFORMATION WAS OBTAINED. PROVIDED PATIENT MEDICAL RECORDS WERE REVIEWED BY A DEPUY MEDICAL PROFESSIONAL. WITH THE LIMITED INFORMATION PROVIDED, IT CANNOT BE DETERMINED THAT THE COMPLAINT IS PRODUCT RELATED. 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 THE ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    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.

    Description of Event or Problem · 1

    LOOSE FEMORAL AND TIBIAL COMPONENTS. PAIN. PATELLA NOT REVISED. UPDATE: THE PATIENT'S MEDICAL RECORDS WERE REVIEWED. THE TIBIAL AND FEMORAL LOOSENING OCCURRED AT THE BONE TO CEMENT AND THE CEMENT TO IMPLANT INTERFACE. COMPETITORS CEMENT WAS USED AT THE TIME OF IMPLANTATION. UPDATED ON: 09/09/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555468 PFC*SIGMA C/S NPOR FE LT SZ2.5 KNEE FEMORAL COMPONENT JWH DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS 121965 347048CB

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention