BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 0° X3 INSERT 36MM ID

    MDR report key: 3022596 · Received March 27, 2013

    Report

    Report Number
    0002249697-2013-01073
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    February 8, 2013
    Report Date
    March 1, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K033716
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6). AN EVENT REGARDING INFECTION INVOLVING A TRIDENT LINER WAS REPORTED. THE EVENT WAS NOT CONFIRMED. REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED MANUFACTURING LOT OR THE STERILITY LOT REFERENCED IN THIS EVENT. 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.

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER HIP DEVICES WERE ALSO LISTED IN THIS REPORT: TRIDENT PSL HA CLUSTER 58MM, CAT# 542-11-58G, LOT# MKT894. V40 COCR LFIT HEAD 36MM/0, CAT# 6260-9-136, LOT# MKN4NX. SIZE 8 ACCOLADE II 132 DEG, CAT# 6720-0837, LOT# 39701304. A 6.5 CANCELLOUS BONE SCREW 25MM, CAT# 2030-6525-1, LOT# MLN2T9. A 6.5 CANCELLOUS BONE SCREW 25MM, CAT# 2030-6525-1, LOT# MLNDTT. 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. MEDICAL RECORDS AND X-RAYS WERE NOT PROVIDED TO STRYKER FOR REVIEW DUE TO THE REPORTING INSTITUTION (B)(4) REGULATIONS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    POSTOPERATIVE DIAGNOSIS: PROSTHETIC JOINT INFECTION.

    Description of Event or Problem · 1

    POSTOPERATIVE DIAGNOSIS: PROSTHETIC JOINT INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126493 TRIDENT 0° X3 INSERT 36MM ID IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH MLNYJ2

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention