BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-TAPER COCR LFIT HEAD 32MM/0

    MDR report key: 3935714 · Received July 15, 2014

    Report

    Report Number
    0002249697-2014-02707
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 23, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LWJ
    PMA / PMN Number
    K993601
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. DEVICE NOT RETURNED TO THE MANUFACTURER .

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS REPORTED FOR THE REPORTED MANUFACTURING LOT THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE OF THE REPORTED EVENT DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT DISLOCATED "LATE". BOUGHT TO OR FOR REVISION OF CUP (55 DEGREE) , SOME APPARENT OSTEOLYSIS. ALVAL TYPE SYMPTOMS WERE FOUND WHEN HIP WAS OPENED. CORROSION ON NECK AND IN FEMORAL HEAD COMPONENT. LINER DID NOT APPEAR TO BE BADLY WORN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT DISLOCATED "LATE". BROUGHT TO OPERATING ROOM FOR REVISION OF CUP (55 DEGREE) , SOME APPARENT OSTEOLYSIS. ALVAL TYPE SYMPTOMS WERE FOUND WHEN HIP WAS OPENED. CORROSION ON NECK AND IN FEMORAL HEAD COMPONENT. LINER DID NOT APPEAR TO BE BADLY WORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412366 C-TAPER COCR LFIT HEAD 32MM/0 IMPLANT LWJ STRYKER ORTHOPAEDICS-MAHWAH 97508302

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention