BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 10° X3 INSERT 32MM ID

    MDR report key: 3010138 · Received March 19, 2013

    Report

    Report Number
    0002249697-2013-01023
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 26, 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 FOLLOWING OTHER HIP DEVICES WERE ALSO LISTED IN THIS REPORT: 32MM -4 LFIT V40 HEAD, CAT# 6260-9-032, LOT# 33833401. ACCOLADE 132 SIZE 2.5, CAT# 6020-2530, LOT# 34353106. TRIDENT PSL HA CLUSTER 50MM, CAT# 542-11-50E, LOT# MJL4D6. 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 DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION PERTAINING TO THE DEVICE REFERENCED IN THIS REPORT (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED BUT NOT MADE AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING INFECTION INVOLVING A TRIDENT 10 DEGREE INSERT 32MM ID WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION NOT BE PERFORMED AS NO ITEMS ASSOCIATED WITH THE EVENT WERE RETURNED OR MADE AVAILABLE FOR IDENTIFICATION OR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED AS NO LOT INFORMATION WAS PROVIDED. A COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED AS NO LOT INFORMATION WAS PROVIDED. THE SOURCE OF THE INFECTION COULD NOT BE DETERMINED AS FURTHER INFORMATION IS NEEDED. 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.

    Description of Event or Problem · 1

    PATIENT PRESENTED WITH AN INFECTED THA. PROSTHESIS WAS REMOVED.

    Description of Event or Problem · 1

    PATIENT PRESENTED WITH AN INFECTED THA. PROSTHESIS WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114571 TRIDENT 10° X3 INSERT 32MM ID IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention