BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 0 DEG INSERT 40MM

    MDR report key: 2941849 · Received February 4, 2013

    Report

    Report Number
    0002249697-2013-00538
    Event Type
    Injury
    Date Received
    February 4, 2013
    Date of Event
    November 21, 2012
    Report Date
    January 11, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K061434
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER HIP DEVICES WERE ALSO LISTED IN THIS REPORT: PRIMARY SECUR-FIT PLUS MAX #11/15, CAT# 6054-1115S, LOT# MJPTAT, C-TAPER COCR LFIT HEAD 40MM/+2.5, CAT# 06-4025, LOT# MLJDDX, TRIDENT PSL WITH PUREFIX HA 60MM, CAT# 542-11-60G, LOT# 38470101. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S INFECTION. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED. WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING INFECTION INVOLVING A TRIDENT 0 DEG INSERT 40MM WAS REPORTED. THE EVENT WAS CONFIRMED. REVIEW OF THE PROVIDED MEDICAL RECORDS BY A CLINICAL CONSULTANT INDICATED, ¿THIS APPARENTLY INFECTED LEFT TOTAL HIP ARTHROPLASTY WAS NOT DEMONSTRATED TO BE RELATED TO ANY FACTORS INVOLVING THE PROSTHETIC COMPONENTS UTILIZED IN THIS CASE.¿ A DEVICE HISTORY REVIEW CONFIRMED ALL DEVICES ACCEPTED INTO FINISHED GOODS CONFORMED TO SPECIFICATION. A COMPLAINT HISTORY REVIEW CONFIRMED NO SIMILAR EVENTS FOR THE REPORTED LOT. 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.

    Description of Event or Problem · 1

    USER FACILITY MEDWATCH REPORT # (B)(4) STATED: "HIP REPLACEMENT TAKEN OUT, INCISION AND DRAINAGE, CULTURES SENT. PATIENT WITH RECENT ONSET OF COMPLAINTS OF INCREASED DRAINAGE, ERYTHEMA, GENERAL MALAISE, GROIN AND THIGH PAIN STATUS POST-LEFT TOTAL HIP ARTHROPLASTY (THA) PERFORMED ONE MONTH PREVIOUS. HE WAS SUBSEQUENTLY ADMITTED AND DIAGNOSED WITH LEFT THA WOUND INFECTION AND UNDERWENT AND UNDERWENT A LEFT THA WOUND I&D (INCISION AND DRAINAGE) WITH COMPONENT EXPLANT TWO MONTHS AFTER ORIGINAL IMPLANT SURGERY DATE."

    Description of Event or Problem · 1

    USER FACILITY MEDWATCH REPORT # (B)(4) STATED: "HIP REPLACEMENT TAKEN OUT, INCISION AND DRAINAGE, CULTURES SENT. PATIENT WITH RECENT ONSET OF COMPLAINTS OF INCREASED DRAINAGE, ERYTHEMA, GENERAL MALAISE, GROIN AND THIGH PAIN STATUS POST-LEFT TOTAL HIP ARTHROPLASTY (THA) PERFORMED ONE MONTH PREVIOUS. HE WAS SUBSEQUENTLY ADMITTED AND DIAGNOSED WITH LEFT THA WOUND INFECTION AND UNDERWENT AND UNDERWENT A LEFT THA WOUND I&D (INCISION AND DRAINAGE) WITH COMPONENT EXPLANT TWO MONTHS AFTER ORIGINAL IMPLANT SURGERY DATE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46058 TRIDENT 0 DEG INSERT 40MM IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH MLD6EX

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention