BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 0° CROSSFIRE INSERT 28 MM ID

    MDR report key: 3887931 · Received June 23, 2014

    Report

    Report Number
    0002249697-2014-02395
    Event Type
    Injury
    Date Received
    June 23, 2014
    Date of Event
    May 30, 2014
    Report Date
    June 2, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K983502
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER DEVICES WERE ALSO LISTED IN THIS REPORT: TRIDENT PSL WITH PUREFIX HA 62MM; CAT# 542-11-62H; LOT# 93259802. A 6.5 CANCELLOUS BONE SCREW 25MM; CAT# 2030-6525-1; LOT# 98998103. ACETABULAR DOME HOLE PLUG; CAT# 2060-0000-1; LOT# 98893703. 6.5 CANCELLOUS BONE SCREW 25MM; CAT# 2030-6525-1; LOT# 98128404. ACCOLADE PLUS TMZF HIP STEM #4; CAT# 6021-0435; LOT# 6090204. 28MM 0MM V40 ALUMINA HEAD; CAT# 6260-7-128; LOT# 4922402. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S INFECTION. 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, BUT NOT MADE AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING INFECTION INVOLVING A TRIDENT 0° CROSSFIRE INSERT 28 MM ID WAS REPORTED. THE EVENT WAS NOT CONFIRMED. -DEVICE HISTORY REVIEW: A DEVICE HISTORY REVIEW CONFIRMED ALL DEVICES ACCEPTED INTO FINISHED GOODS CONFORMED TO SPECIFICATION. -COMPLAINT HISTORY REVIEW: A COMPLAINT HISTORY REVIEW CONFIRMED NO OTHER SIMILAR EVENTS FOR THE REPORTED LOT OR STERILE LOT. CONCLUSIONS: THE SOURCE OF THE INFECTION COULD NOT BE DETERMINED AS PATIENT INFORMATION, CLINICAL HISTORY, AND RESULTS OF BLOODWORK FOR INFECTION WERE NOT PROVIDED. A CAPA TREND ANALYSIS WAS CONDUCTED FOR THE REPORTED FAILURE MODE AND CONCLUDED INFECTION IS MOST LIKELY A RESULT FROM OTHER FACTORS NOT NECESSARILY RELATED TO THE DEVICE IN THE HEALTHCARE FACILITY SETTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT RIGHT HIP COMPONENTS WERE EXPLANTED DUE TO INFECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT RIGHT HIP COMPONENTS WERE EXPLANTED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364967 TRIDENT 0° CROSSFIRE INSERT 28 MM ID IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH 02494603

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention