BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 0 DEG X3 INSERT 32MM HEAD

    MDR report key: 3396973 · Received October 9, 2013

    Report

    Report Number
    0002249697-2013-03240
    Event Type
    Injury
    Date Received
    October 9, 2013
    Date of Event
    September 14, 2013
    Report Date
    September 14, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K033716
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING INFECTION INVOLVING A TRIDENT 0 DEG X3 INSERT 32MM HEAD WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION COULD NOT BE PERFORMED AS NO ITEMS ASSOCIATED WITH THE EVENT WERE RETURNED OR MADE AVAILABLE FOR EVALUATION. A DEVICE HISTORY REVIEW CONFIRMED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINISHED GOODS WITH NO REPORTED DISCREPANCIES. A COMPLAINT HISTORY REVIEW CONFIRMED NO SIMILAR EVENTS FOR THE REPORTED LOT OR STERILE LOT. 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.

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER HIP DEVICES WERE ALSO LISTED IN THIS REPORT: CITATION TMZF HA SHORT SIZE#5R; CAT # 6265-5215; LOT# 29432001. C-TAPER COCR LFIT HEAD 32MM/+5; CAT# 06-3205; LOT# MLPHPR. PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 50MM; CAT# 502-03-50D; LOT# MMK645. SECUR-FIT MAX 132 HIP STEM #8; CAT# 6051-0830S; LOT# MMJNDM. 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 (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD LINER EXCHANGED DUE TO INFECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD LINER EXCHANGED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512758 TRIDENT 0 DEG X3 INSERT 32MM HEAD IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH MMK7E1

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention