BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIX UNI-KNEE TIB TRAY SIZE 3

    MDR report key: 3130089 · Received May 24, 2013

    Report

    Report Number
    0002249697-2013-01785
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 7, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    HRY
    PMA / PMN Number
    K923011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING PAIN AND DISEASE PROGRESSION LEADING TO REVISION SURGERY INVOLVING A UNIX BASEPLATE COMPONENT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. A PHOTOGRAPH OF THE BASEPLATE WAS PROVIDED WITHIN AN IMPLANT RETRIEVAL REPORT THAT THE HOSPITAL HAD COMPLETED. THE BASEPLATE IS SCRATCHED BUT APPEARS NORMAL FOR AN EXPLANTED DEVICE. DEVICE HISTORY REVIEW: THE DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED DUE TO THE LIMITED INFORMATION PROVIDED. FURTHER INFORMATION SUCH AS PRE- AND POST-OPERATIVE X-RAYS, OPERATIVE REPORTS AND FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    OTHER DEVICES LISTED IN THIS REPORT: CATALOG NO, LOT CODE, 4540-0308, UNIX UNI KNEE TIB BEAR INSERT CPPGF01A S4510003L, UNIX HA FEMORAL SIZE 3 LFT UNK, 2029-5530-1; 5.5 CANCELLOUS BONE SCREW 30MM 10253358MY 2029-5540-1, 5.5; CANCELLOUS BONE SCREW 40MM EOTMHA0030MAX. AT THIS TIME, IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    REVISION OF UNIX DUE TO PAIN AND PROGRESSION OF MEDIAL COMPARTMENT OSTEOARTHRITIS. POSSIBLE INFECTION AND MINIMAL ONGROWTH. IMPLANTS REMOVED, NO NEW PROSTHESIS IMPLANTED UNTIL PATHOLOGY RESULTS COME BACK.

    Description of Event or Problem · 1

    REVISION OF UNIX DUE TO PAIN AND PROGRESSION OF MEDIAL COMPARTMENT OSTEOARTHRITIS. POSSIBLE INFECTION AND MINIMAL ONGROWTH. IMPLANTS REMOVED, NO NEW PROSTHESIS IMPLANTED UNTIL PATHOLOGY RESULTS COME BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231805 UNIX UNI-KNEE TIB TRAY SIZE 3 IMPLANT HRY STRYKER ORTHOPAEDICS-MAHWAH LABMP

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention