BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-TAPER COCR LFIT HEAD 36MM/0

    MDR report key: 3936180 · Received July 15, 2014

    Report

    Report Number
    0002249697-2014-02714
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 24, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K021310
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE INVESTIGATION RESULTS WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) CENTIMETERS IN HEIGHT. AN EVENT REGARDING A PERIPROSTHETIC FEMORAL FRACTURE AND SUBSEQUENT DISLOCATION INVOLVING A C-TAPER COCR HEAD WAS REPORTED. THE REPORTED DISLOCATION WAS CONFIRMED. THE C-TAPER HEAD WAS RETURNED DISASSEMBLED FROM THE TRIDENT INSERT. DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THIS LOT. CONCLUSIONS: THE INVESTIGATION CONCLUDED THAT THE PERIPROSTHETIC FEMORAL FRACTURE LIKELY LED TO JOINT INSTABILITY, WHICH LED TO THE REPORTED DISLOCATION.

    Description of Event or Problem · 1

    LINER AND HEAD REVISED FROM TRIDENT 10 DEGREE 36F TO TRIDENT ELEVATED LINER 36F AND HEAD FROM 36MM 0 TO 36MM +10. (B)(6) SUSPECTS FEMORAL FRACTURE HAS LOOSENED FEMORAL COMPONENT, LEADING TO STEM SUBSIDENCE AND INSTABILITY OF JOINT LEADING TO DISLOCATION. DISLOCATION REQUIRED REDUCTION IN HOSPITAL. ADDITIONAL INFORMATION: (B)(6) BELIEVES THE FRACTURE MAY HAVE BEEN SUSTAINED DURING THE ARTHROPLASTY AND DOES NOT SEE IT AS A "FAILURE" OF THE COMPONENTS.

    Description of Event or Problem · 1

    LINER AND HEAD REVISED FROM TRIDENT 10 DEGREE 36F TO TRIDENT ELEVATED LINER 36F AND HEAD FROM 36MM 0 TO 36MM +10. MR S. SUSPECTS FEMORAL FRACTURE HAS LOOSENED FEMORAL COMPONENT, LEADING TO STEM SUBSIDENCE AND INSTABILITY OF JOINT LEADING TO DISLOCATION. DISLOCATION REQUIRED REDUCTION IN HOSPITAL. ADDITIONAL INFORMATION: MR. (B)(6) BELIEVES THE FRACTURE MAY HAVE BEEN SUSTAINED DURING THE ARTHROPLASTY AND DOES NOT SEE IT AS A "FAILURE" OF THE COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412179 C-TAPER COCR LFIT HEAD 36MM/0 IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH MMPMVW

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention