BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN TRIDENT 36MM F X3 10DEG POLY INSERT

    MDR report key: 7959766 · Received October 12, 2018

    Report

    Report Number
    0002249697-2018-03298
    Event Type
    Injury
    Date Received
    October 12, 2018
    Date of Event
    March 24, 2009
    Report Date
    December 18, 2018
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT REGARDING INFECTION INVOLVING AN UNKNOWN TRIDENT LINER WAS REPORTED. THE EVENT WAS CONFIRMED BY CLINICIANS REVIEW. METHOD & RESULTS: PRODUCT EVALUATION AND RESULTS: A VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTION WAS NOT PERFORMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS AS IT REMAINS IMPLANTED. CLINICIAN REVIEW: "ON (B)(6) 2009 A REVISION OF THE RIGHT TOTAL HIP WAS "PERFORMED" FOR RIGHT HIP PAIN, STATUS-POST TOTAL HIP ARTHROPLASTY. ONE-HALF HOUR POST-OPERATIVE A GRAM STAIN REPORT WAS "1 + ORGANISMS" AND THE PATIENT WAS BEGUN ON ANTIBIOTICS. ON A POST-OPERATIVE VISIT OF (B)(6) 2009 THE STAPLES WERE REMOVED AND NO SIGN OF INFLAMMATION OR INFECTION WERE NOTED. ON A VISIT OF (B)(6) 2009 THE PATIENT WAS DOING WELL.. PRODUCT HISTORY REVIEW: A REVIEW OF THE PRODUCT HISTORY RECORDS COULD NOT BE PERFORMED AS THE DEVICE LOT NUMBER IS UNKNOWN. COMPLAINT HISTORY REVIEW: A COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. CONCLUSIONS: THE EVENT WAS CONFIRMED AS PER CLINICIANS REVIEW. A REVIEWED OF PROVIDED MEDICAL RECORDS BY CONSULTANT CLINICIAN REVEALED THAT, "ON (B)(6) 2009 A REVISION OF THE RIGHT TOTAL HIP WAS "PERFORMED" FOR RIGHT HIP PAIN, STATUS-POST TOTAL HIP ARTHROPLASTY.[...] ONE-HALF HOUR POST-OPERATIVE A GRAM STAIN REPORT WAS "1 ORGANISMS" AND THE PATIENT WAS BEGUN ON ANTIBIOTICS. ON A POST-OPERATIVE VISIT OF (B)(6) 2009 THE STAPLES WERE REMOVED AND NO SIGN OF INFLAMMATION OR INFECTION WERE NOTED. ON A VISIT OF (B)(6) 2009 THE PATIENT WAS DOING WELL. IN THIS CASE OF SUBCLINICAL INFECTION OF THE RIGHT TOTAL HIP ARTHROPLASTY INITIALLY TREATED WITH I&D EARLY POST-OPERATIVE PRIMARY SURGERY AND LATER WITH A POSITIVE GRAM STAIN AT REVISION, PAIN APPEARED RELATED TO TROCHANTERIC BURSITIS, ACETABULAR IMPINGEMENT, AND POSSIBLE INFECTION. REPOSITIONING THE ACETABULAR COMPONENT INTO ANTEVERSION APPARENTLY RESOLVED THE IMPINGEMENT PROBLEMS AND ALSO THE POSSIBLE ILIOPSOAS TENDINITIS. NO EXAMINATION OF THE EXPLANTED COMPONENTS IS AVAILABLE. BLACK MARKINGS DESCRIBED ON THE ALUMINA HEAD ARE CONSISTENT WITH REPEATED SUBLUXATIONS. THERE IS NO EVIDENCE THAT FACTORS OF FAULTY PROSTHETIC DESIGN, MANUFACTURING, OR MATERIALS WERE RESPONSIBLE FOR THIS CLINICAL SITUATION." NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Description of Event or Problem · 0

    AS PER REVIEW OF MEDICAL RECORDS: "ONE-HALF HOUR POST-OPERATIVE A GRAM STAIN REPORT WAS "1 ORGANISMS" AND THE PATIENT WAS BEGUN ON ANTIBIOTICS." THIS PI IS FOR INFECTION.

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: ACETABULAR DOME HOLE PLUG; CAT#2060-0000-1; LOT#UNKNOWN. 6.5 CANCELLOUS BONE SCREW 40MM; CAT#2030-6540-1; LOT#UNKNOWN. D-M 2.0MM BEADED CABLE SET VIT; CAT#6704-0-520; LOT#UNKNOWN. UNKNOWN ACCOLADE TMZ HIP SYSTEM STEM #7; CAT#UNKNOWN; LOT#UNKNOWN. UNKNOWN DELTA CERAMIC V40 36MM HEAD; CAT#UNKNOWN; LOT#UNKNOWN. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE.

    Description of Event or Problem · 1

    AS PER REVIEW OF MEDICAL RECORDS: "ONE-HALF HOUR POST-OPERATIVE A GRAM STAIN REPORT WAS "1 + ORGANISMS" AND THE PATIENT WAS BEGUN ON ANTIBIOTICS." THIS PI IS FOR INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801760 UNKNOWN TRIDENT 36MM F X3 10DEG POLY INSERT HIP IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other