BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 0° CROSSFIRE INSERT 32 MM ID

    MDR report key: 5894261 · Received August 22, 2016

    Report

    Report Number
    0002249697-2016-02678
    Event Type
    Injury
    Date Received
    August 22, 2016
    Date of Event
    July 25, 2016
    Report Date
    July 25, 2016
    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

    AN EVENT REGARDING INFECTION INVOLVING A TRIDENT LINER WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: A VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTION COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. MEDICAL RECORDS RECEIVED AND EVALUATION: NO MEDICAL RECORDS OR X-RAYS WERE MADE AVAILABLE FOR EVALUATION. DEVICE HISTORY REVIEW: ALL DEVICES IN THE REPORTED LOT WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE REPORTED LOT AND STERILE LOT. CONCLUSIONS: THE SOURCE OF THE INFECTION COULD NOT BE DETERMINED AS PATIENT INFORMATION, CLINICAL HISTORY, AND RESULTS OF BLOOD-WORK 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. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND/OR INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND/OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    OTHER DEVICES LISTED IN THIS REPORT: CAT. NO.: 542-11-52E, TRIDENT PSL HA CLUSTER 52MM, LOT CODE: 1854001. CAT. NO.: 6020-0537, ACCOLADE TMZF HIP STEM #5, LOT CODE: 2032701. CAT. NO.: 6260-7-032, 32MM -4MM V40 ALUMINA HEAD, LOT CODE: 3743802. CAT. NO.: 2030-6525-1 6.5, CANCELLOUS BONE SCREW 25MM, LOT CODE: 72576902. CAT. NO.: 2030-6550-1 6.5' CANCELLOUS BONE SCREW 50MM, LOT CODE: 31607802. AT THIS TIME, IT CANNOT BE DETERMINED IF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT¿S INFECTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE SUBMITTED IN A FOLLOW UP REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    LEFT HIP REVISION DUE TO INFECTION.

    Description of Event or Problem · 1

    LEFT HIP REVISION DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546236 TRIDENT 0° CROSSFIRE INSERT 32 MM ID PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH STRYKER ORTHOPAEDICS-MAHWAH 03135301

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention