BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3093008 · Received May 3, 2013

    Report

    Report Number
    0002249697-2013-01539
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    July 27, 2009
    Report Date
    April 11, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING TIBIAL COMPONENT LOOSENING INVOLVING AN EIUS UNICOMPARTMENTAL SYSTEM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE DETERMINED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION AND INSUFFICIENT MEDICAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN EIUS UNICOMPARTMENTAL SYSTEM. THIS EVENT WAS REPORTED THROUGH AN ATTORNEY, AS A RESULT OF A LEGAL CLAIM. DUE TO THE ONGOING LITIGATION NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT THE PATIENT ALLEGES SHE UNDERWENT A RIGHT KNEE UNICOMPARTMENTAL SURGICAL PROCEDURE ON OR ABOUT (B)(6) 2009. IT IS FURTHER ALLEGED THAT FOLLOWING THE SURGERY, THE PATIENT EXPERIENCED A GREAT DEAL OF SWELLING, PAIN AND LOSS OF MOVEMENT THAT PERSISTED AND WORSENED OVER TIME. IT IS FURTHER ALLEGED THAT IN 2011, THE PATIENT HAD A SECOND SURGERY DUE TO TIBIAL COMPONENT LOOSENING.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT THE PATIENT ALLEGES SHE UNDERWENT A RIGHT KNEE UNICOMPARTMENTAL SURGICAL PROCEDURE ON OR ABOUT (B)(6) 2009. IT IS FURTHER ALLEGED THAT FOLLOWING THE SURGERY, THE PATIENT EXPERIENCED A GREAT DEAL OF SWELLING, PAIN AND LOSS OF MOVEMENT THAT PERSISTED AND WORSENED OVER TIME. IT IS FURTHER ALLEGED THAT IN 2011, THE PATIENT HAD A SECOND SURGERY DUE TO TIBIAL COMPONENT LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195454 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention