BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS CON SZ E HI 60MM

    MDR report key: 3746401 · Received April 11, 2014

    Report

    Report Number
    0001825034-2014-02744
    Event Type
    Injury
    Date Received
    April 11, 2014
    Date of Event
    February 21, 2014
    Report Date
    March 13, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK090757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR ASSOCIATED DEVIATION. REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH ISO 11137-2. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 2 STATES, ¿EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION." THIS REPORT IS NUMBER 1 OF 6 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-02744 / 02749).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT ENROLLED IN A CLINICAL STUDY AND UNDERWENT A TOTAL LEFT HIP ARTHROPLASTY ON (B)(6) 2014. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2014 FOR AN UNKNOWN REASON. TAPERLOC STEM WAS REMOVED AND ARCOS STEM IMPLANTED. IT WAS FURTHER REPORTED THAT ON OR ABOUT (B)(6) 2014, PATIENT CONTRACTED AN INFECTION WHILE IN REHABILITATION. INTRAVENOUS ANTIBIOTICS WERE ADMINISTERED AND TREATMENT WAS RESOLVED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220807 ARCOS CON SZ E HI 60MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 179160

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R