BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 0° X3 INSERT 36MM ID

    MDR report key: 3111023 · Received May 14, 2013

    Report

    Report Number
    0002249697-2013-01662
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 19, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K983382
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER HIP DEVICES WERE ALSO LISTED IN THIS REPORT:CAT# DESCRIPTION LOT#623-00-36F TRIDENT 0° X3 INSERT 36MM ID MLRH1J09390112 EXETER 2.5 I M PLUG 12MM NA1SFL60900580-1-443 EXETER V40 STEM 44MM NO 3 G3321124IT 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) WAS REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. DEVICE NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING INFECTION INVOLVING A TRIDENT X3 INSERT WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DHR REVIEW DETERMINED THAT THE LOT WAS MANUFACTURED AND PACKED TO SPECIFICATION. A REVIEW OF THE STERILIZATION RECORDS VERIFIED THE STERILITY OF THE REPORTED PRODUCT LOT. CHR REVIEW CONFIRMED THAT THERE HAVE BEEN NO SIMILAR EVENTS FOR THE LOT OR STERILE LOT. THE EXACT CAUSE OF THE REPORTED INFECTION COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. A CAPA TREND ANALYSIS WAS CONDUCTED FOR THE REPORTED FAILURE MODE AND CONCLUDED INFECTION IS A KNOWN POSSIBLE ADVERSE OUTCOME OF SURGERY AND IS BEYOND STRYKER'S CONTROL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REMOVED PATIENT'S REJUVENATE IMPLANTS (B)(6) 2013. PATIENT HAD INFECTION REMOVED SOFT TISSUE AND FLUID, CHANGED BALL AND LINER, IRRIGATED AND DEBRIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT REMOVED PATIENT'S REJUVENATE IMPLANTS (B)(6) 2013. PATIENT HAD INFECTION REMOVED SOFT TISSUE AND FLUID, CHANGED BALL AND LINER, IRRIGATED AND DEBRIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211746 TRIDENT 0° X3 INSERT 36MM ID IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH MLRH1J

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention