BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI LOW PROFILE SCREW 6.5X30MM

    MDR report key: 2943019 · Received February 5, 2013

    Report

    Report Number
    0001825034-2013-00223
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    December 31, 2012
    Report Date
    January 7, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK082446
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. 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 DEVIATION. 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 5 OF 8 MDRS FILED FOR THE SAME EVENT (REFERENCE 0001825034 - 2013- 00218/00219 AND 00221/00226). REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT INITIAL HIP ARTHROPLASTY WITH UNKNOWN PRODUCTS ON AN UNKNOWN DATE. SUBSEQUENTLY, PATIENT WAS REVISED TO BIOMET CUP, BIOMET UK LINER AND A COMPETITOR'S HEAD ON (B)(6) 2012 DUE TO SUSPECTED INFECTION. FURTHER, PATIENT WAS REVISED ON (B)(6) 2012 DUE TO ANOTHER SUSPECTED INFECTION AND A BIOMET LINER WAS IMPLANTED ALONG WITH A REPLACEMENT RING. ANOTHER REVISION PROCEDURE OCCURRED ON (B)(6) 2012 DUE TO DISLOCATION AND ANOTHER SUSPECTED INFECTION. ALL PRODUCT WAS REMOVED AND REPLACED WITH BIOMET PRODUCT AND COMPETITOR HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48504 TI LOW PROFILE SCREW 6.5X30MM PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 625030

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R