BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V40 COCR LFIT HEAD 36MM/0

    MDR report key: 3140313 · Received May 31, 2013

    Report

    Report Number
    0002249697-2013-01824
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 6, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K022077
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. NOT RETURNED.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING CORROSION INVOLVING A V40 COCR LFIT HEAD 36MM/0 WAS REPORTED. THE EVENT WAS NOT CONFIRMED. A PHOTOGRAPH OF THE REPORTED DEVICE NOTED BLACK STAINING ON THE FEMALE TAPER. A DEVICE HISTORY REVIEW CONFIRMED ALL DEVICES ACCEPTED INTO FINISHED GOODS CONFORMED TO SPECIFICATION. A COMPLAINT HISTORY REVIEW CONFIRMED NO OTHER SIMILAR EVENTS FOR THE REPORTED LOT CODE. WHILE THE PRESENCE OF BLACK STAINING WAS CONFIRMED AT THE REVISION SURGERY, IT DOES NOT NECESSARILY MEAN THAT THERE IS CORROSION OR OTHER METAL-RELATED PROBLEM. BIOLOGICAL DEBRIS CAN ALSO LEAVE A BLACK STAIN. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE FURTHER INFORMATION IS NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING THE ROOT CAUSE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON REVISED PATIENT'S RIGHT ACCOLADE TMZF HIP DUE TO CORROSION AT THE HEAD NECK JUNCTION. SURGEON ALSO STATED THAT THERE WAS FLUID NOTICED ON THE MRI SCAN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON REVISED PATIENTS' RIGHT ACCOLADE TMZF HIP DUE TO CORROSION AT THE HEAD NECK JUNCTION. SURGEON ALSO STATED THAT THERE WAS FLUID NOTICED ON THE MRI SCAN. PATIENT ALSO HAS LEGAL REPRESENTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241347 V40 COCR LFIT HEAD 36MM/0 IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH 67PMLE

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| O| R