BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 0 DEG INSERT 40MM

    MDR report key: 2964587 · Received February 15, 2013

    Report

    Report Number
    0002249697-2013-00709
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 1, 2013
    Report Date
    February 1, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K062419
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER HIP DEVICES WERE ALSO LISTED IN THIS REPORT: PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 56MM, CAT# 502-03-56E, LOT# MJPV31. ACETABULAR DOME HOLE PLUG, CAT# 2060-0000-1, LOT# LJK0D0. 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. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. FURTHERMORE, A REVIEW OF THE STERILIZATION RECORDS VERIFIED THE STERILITY OF THE REPORTED PRODUCT LOTS. COMPLAINT HISTORY REVIEW THERE HAVE BEEN NO OTHER EVENTS FOR THIS LOT. REVIEW OF THE STERILIZATION RECORDS VERIFIED THE STERILITY OF THE REPORTED PRODUCT LOTS. IT IS NOTED THAT WHEN THE DOUBLE BARRIER PACKAGING IS OPENED, THE STERILITY OF ANY DEVICE BECOMES A FUNCTION OF HANDLING AND SURGICAL TECHNIQUE AND IS BEYOND STRYKER'S CONTROL.

    Description of Event or Problem · 1

    USER FACILITY REPORT (B)(4) STATED: "EVENT DESC: PATIENT WAS ADMITTED WITH AN INFECTED RIGHT TOTAL HIP REPLACEMENT FROM (B)(6) 2010. THE PROSTHESIS WAS EXPLANTED IN (B)(6) 2012. NOT A MALFUNCTION."

    Description of Event or Problem · 1

    USER FACILITY REPORT # (B)(4) STATED: "EVENT DESC: PATIENT WAS ADMITTED WITH AN INFECTED RIGHT TOTAL HIP REPLACEMENT FROM (B)(6) 2010. THE PROSTHESIS WAS EXPLANTED IN (B)(6) 2012. NOT A MALFUNCTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69049 TRIDENT 0 DEG INSERT 40MM IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH MJMR9D

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention