BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERSAL STEM 115X16MM FLUTED

    MDR report key: 3963169 · Received July 29, 2014

    Report

    Report Number
    1818910-2014-24328
    Event Type
    Injury
    Date Received
    July 29, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 8, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.1818910
    Product Code
    JWH
    PMA / PMN Number
    PK063633
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 X-RAYS WERE PROVIDED. REVIEW OF THE SUPPLIED X-RAYS CONFIRMED THE REPORTED DEVICE LOOSENING. THE ROOT CAUSE OF THE DEVICE LOOSENING IS UNKNOWN. BASED ON THE PROVIDED X-RAY IMAGES, THERE IS NO INDICATION THAT THE DEVICES WERE DEFECTIVE OR ADVERSELY CONTRIBUTED TO THE PATIENT'S CONDITION. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY MANUFACTURING DEVIATIONS OR ANOMALIES. NO EVIDENCE WAS FOUND SUGGESTING PRODUCT ERROR WAS A CONTRIBUTING FACTOR AND 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

    KNEE REVISION: PERFORMED ON (B)(4) 2014 DUE TO LOOSENING OF IMPLANTS. PRIMARY: KNEE REPLACEMENT PERFORMED ON (B)(6) 2012 BY POSSIBLY SAME SURGEON. IN ADDITION, THE SURGEON HAD ADVISED THAT DEPUY COMPONENTS WERE NOT REVISED DURING THE FIRST REVISION ON (B)(6) 2012. ON THIS DATE, SROM HINGE WAS IMPLANTED ON PATIENT. AS THIS IS NOT A DEPUY REVISION, COULD YOU PLEASE VOID CASE (B)(4) WHICH WE HAVE LOGGED RETROSPECTIVELY IN RELATION TO THIS PATIENT¿S FIRST REVISION?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441444 UNIVERSAL STEM 115X16MM FLUTED KNEE OTHER IMPLANT JWH DEPUY ORTHOPAEDICS, INC.1818910 214481

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention