BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EIUS UNI TIB MED 6MM LM/RL

    MDR report key: 3213677 · Received July 9, 2013

    Report

    Report Number
    0002249697-2013-02231
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 1, 2008
    Report Date
    June 11, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    NPJ
    PMA / PMN Number
    K052917
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION IN THIS REPORT WAS PROVIDED BY LEGAL AFFAIRS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE DEVICES ARE NOT AVAILABLE DUE TO THE ONGOING LITIGATION. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THE EVENT WAS NOT CONFIRMED AS NO DEVICE WAS PROVIDED FOR REVIEW AND INSUFFICIENT MEDICAL RECORDS WERE PROVIDED FOR REVIEW. DEVICE HISTORY REVIEW: ALL DEVICES ACCEPTED INTO FINAL STOCK CONFORMED TO SPECIFICATION. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO PREVIOUS REPORTED EVENTS FOR THE REPORTED LOT ID. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE THE REPORTED DEVICE WAS NOT RETURNED AND INSUFFICIENT MEDICAL RECORDS WERE PROVIDED FOR REVIEW. BASED ON THE INFORMATION PROVIDED AT THE TIME OF THE INVESTIGATION, NO MANUFACTURING NONCONFORMANCES HAVE BEEN IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT BEGAN TO EXPERIENCE PAIN FOLLOWING HER INITIAL (B)(6) 2008 SURGERY. IT WAS REPORTED THAT ON OR ABOUT (B)(6) 2009, THE PATIENT UNDERWENT A PROCEDURE TO REMOVE THE DEVICE AND MAKE ROOM FOR A TOTAL KNEE REPLACEMENT. THE PATIENT FURTHER ALLEGES THAT SINCE THE SECOND SURGERY, SHE CONTINUES TO EXPERIENCE PAIN AND LACK OF MOBILITY IN HER KNEE.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT BEGAN TO EXPERIENCE PAIN FOLLOWING HER INITIAL (B)(6) 2008 SURGERY. IT WAS REPORTED THAT ON OR ABOUT (B)(6) 2009, THE PATIENT UNDERWENT A PROCEDURE TO REMOVE THE DEVICE AND MAKE ROOM FOR A TOTAL KNEE REPLACEMENT. THE PATIENT FURTHER ALLEGES THAT SINCE THE SECOND SURGERY, SHE CONTINUES TO EXPERIENCE PAIN AND LACK OF MOBILITY IN HER KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312064 EIUS UNI TIB MED 6MM LM/RL IMPLANT NPJ STRYKER ORTHOPAEDICS-MAHWAH 11HDN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention