BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 0° X3 INSERT 36MM ID

    MDR report key: 3910361 · Received July 2, 2014

    Report

    Report Number
    0002249697-2014-02487
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 6, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K033716
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DELTA V-40 CERAMIC HEAD 36/+7,5; CAT# 6570-0-736; LOT# 23850901 WAS ALSO LISTED IN THIS REPORT. 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 RETAINED BY THE DOCTOR AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. 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 ACETABULAR LINER WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION COULD NOT BE PERFORMED AS THE SUBJECT DEVICE WAS NOT RETURNED. -MEDICAL RECORDS RECEIVED AND EVALUATION: INSUFFICIENT MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. -DEVICE HISTORY REVIEW INDICATED THE DEVICES ACCEPTED INTO FINAL STOCK FROM THE REPORTED LOT WERE FREE FROM DISCREPANCIES. -COMPLAINT HISTORY REVIEW FOUND NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED FOR THE SUBJECT MANUFACTURING LOT OR STERILE LOT. CONCLUSIONS: REVIEW OF THE EVENT BY STRYKER STERILIZATION SCIENCES CONCLUDED "BASED ON THE DATA REVIEWED, IT HAS BEEN DETERMINED THAT THE INTRODUCTION OF THE REPORTED CAUSATIVE AGENT OF THE POST-OPERATION INFECTION WAS NOT VIA THE MEDICAL DEVICES" THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE OF THE REPORTED INFECTION DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    PATIENT HAD A LEFT THA AT EMANUEL HOSPITAL ON (B)(6) 2008. PATIENT RECENTLY HAS BECOME CHRONICALLY SEPTIC, DUE A (B)(6) INFECTION FROM A CUT ON HIS KNEE, DOCTOR OPTED TO REMOVE THE POLY AND CERAMIC AND REPLACE THEM WITH NEW COMPONENTS AFTER 9000CC OF PULSLAVAGE IRRIGATION.

    Description of Event or Problem · 1

    PATIENT HAD A LEFT THA (B)(6) 2008. PATIENT RECENTLY HAS BECOME CHRONICALLY SEPTIC, DUE A MRSA INFECTION FROM A CUT ON HIS KNEE, DOCTOR OPTED TO REMOVE THE POLY AND CERAMIC AND REPLACE THEM WITH NEW COMPONENTS AFTER 9000CC OF PULSLAVAGE IRRIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388210 TRIDENT 0° X3 INSERT 36MM ID IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH E0XMPA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention