BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL

    MDR report key: 4241447 · Received November 10, 2014

    Report

    Report Number
    0002249697-2014-04215
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    December 22, 2013
    Report Date
    September 19, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K013676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME DUE TO THE ONGOING LITIGATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. NOT RETURNED.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING DISLOCATION INVOLVING A TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL WAS NOT CONFIRMED. CONCLUSION: A REVIEW OF THE PATIENT¿S MEDICAL RECORDS INDICATED A TRIDENT INSERT WAS IMPLANTED WITH A BIOMET HEAD. BASED ON THE PROVIDED INFORMATION, THE PRODUCT REPORTED IN THIS INVESTIGATION DID NOT CONTRIBUTE TO THE EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2013 A REVISION OF THE LEFT TOTAL HIP ARTHROPLASTY WAS PERFORMED FOR A DIAGNOSIS OF DISLOCATED LEFT HIP REVISION. AN OPERATIVE REPORT DESCRIBES GENERAL ANESTHESIA AND USE OF THE PREVIOUS INCISION. A CLOSED REDUCTION UNDER GENERAL ANESTHESIA "NOT AS STABLE AS WE WOULD WANT AND STILL APPEARED SHORT" IS NOTED. AT SURGERY A HEMATOMA WAS EVACUATED, THE STEM WAS REMOVED WITH A SLAP HAMMER, AND REMOVED THE ACETABULAR LINER, TWO SCREWS, AND THE CUP WITH THE EXPLANT DEVICE. THE ACETABULUM WAS RE-REAMED TO MEDIALIZE MORE AND INSERTED A 58 BIOMET CUP WITH SCREWS AND A NEW 14/150 BIOMET STEM WITH A 40/PLUS-9 HEAD. UNCOMPLICATED SURGERY WAS DESCRIBED AND THE PATIENT WAS SUBSEQUENTLY DISCHARGED ON (B)(6) 2013. THERE IS NO DOCUMENTED FOLLOW-UP SUBSEQUENT TO THIS OPERATIVE REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2013 A REVISION OF THE LEFT TOTAL HIP ARTHROPLASTY WAS PERFORMED FOR A DIAGNOSIS OF DISLOCATED LEFT HIP REVISION. AN OPERATIVE REPORT DESCRIBES GENERAL ANESTHESIA AND USE OF THE PREVIOUS INCISION. A CLOSED REDUCTION UNDER GENERAL ANESTHESIA "NOT AS STABLE AS WE WOULD WANT AND STILL APPEARED SHORT" IS NOTED. AT SURGERY A HEMATOMA WAS EVACUATED, THE STEM WAS REMOVED WITH A SLAP HAMMER, AND REMOVED THE ACETABULAR LINER, TWO SCREWS, AND THE CUP WITH THE EXPLANT DEVICE. THE ACETABULUM WAS RE-REAMED TO MEDIALIZE MORE AND INSERTED A 58 BIOMET CUP WITH SCREWS AND A NEW 14/150 BIOMET STEM WITH A 40/PLUS-9 HEAD. UNCOMPLICATED SURGERY WAS DESCRIBED AND THE PATIENT WAS SUBSEQUENTLY DISCHARGED ON (B)(6) 2013. THERE IS NO DOCUMENTED FOLLOW-UP SUBSEQUENT TO THIS OPERATIVE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721827 TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 28294201

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention