BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 0° X3 INSERT 36MM ID

    MDR report key: 3253167 · Received July 29, 2013

    Report

    Report Number
    0002249697-2013-02480
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    July 4, 2013
    Report Date
    July 4, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K033716
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER HIP DEVICES WERE ALSO LISTED IN THIS REPORT: DELTA V-40 CERAMIC HEAD 36/+5; CAT# 6570-0-236; LOT# 43479203 27MM MOD REV HIP BODY/BOLT STDCOMPONENT LEVEL 9006-1-027; CAT# 6276-1-027; LOT# 42983602. MOD CON DIST STEM 17 X 155 MM; CAT# 6276-7-017; LOT# CAXNB20A. PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 58MM; CAT# 502-03-58F; LOT# MMHK17. 6.5 CANCELLOUS BONE SCREW 45MM; CAT# 2030-6545-1; LOT# MMJ7E5. 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, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    THERE WERE NO REPORTED DISCREPANCIES AND THERE WERE NO OTHER EVENTS FOR THE REFERENCED LOT. DEVICE EVALUATION COULD NOT BE PERFORMED AS NO ITEMS ASSOCIATED WITH THE EVENT WERE RETURNED OR MADE AVAILABLE FOR IDENTIFICATION OR EVALUATION. NO MEDICAL RECORDS WERE MADE AVAILABLE FOR EVALUATION. THE SOURCE OF THE INFECTION COULD NOT BE DETERMINED AS PATIENT INFORMATION, CLINICAL HISTORY, AND RESULTS OF BLOOD WORK FOR INFECTION WERE NOT PROVIDED. INFECTION IS A KNOWN POSSIBLE ADVERSE OUTCOME OF SURGERY, AS NOTED IN THE INSTRUCTIONS FOR USE. ALL STRYKER PRODUCTS SOLD AS STERILE ARE VALIDATED TO A MINIMUM STERILITY ASSURANCE LEVEL (SAL) OF 10-6 IN ACCORDANCE TO APPLICABLE ISO STANDARDS. WHEN THE STERILE BARRIER OF ANY DEVICE IS OPENED, THE STERILITY OF THAT DEVICE BECOMES A FUNCTION OF HANDLING AND SURGICAL TECHNIQUE AND IS BEYOND STRYKER¿S CONTROL. INFECTION DUE TO BACTERIAL CONTAMINATION, AS SUPPLIED FROM THE MANUFACTURER, IS AN EXTREMELY RARE EVENT. 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. THE REPORTED EVENT REGARDING POSSIBLE INFECTION INVOLVING A TRIDENT 0 DEGREE INSERT WAS NOT CONFIRMED.

    Description of Event or Problem · 1

    EXPLANT OF REVISION COMPONENTS DUE TO INFECTION.

    Description of Event or Problem · 1

    EXPLANT OF REVISION COMPONENTS DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352684 TRIDENT 0° X3 INSERT 36MM ID IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH MMDLWT

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention