BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERAMIC OPTION TYPE 1 TAPER SLEEVE -3

    MDR report key: 3903359 · Received June 30, 2014

    Report

    Report Number
    0001825034-2014-05853
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    February 1, 2012
    Report Date
    June 6, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LZO
    PMA / PMN Number
    PK082996
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 DEVIATION. REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH (B)(4). THIS REPORT IS NUMBER 2 OF 8 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2014-05852/05859).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN A CLINICAL STUDY UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2011. A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2012 TO REMOVE AND REPLACE THE ACETABULAR LINER, MODULAR HEAD AND TAPER FOR AN UNKNOWN REASON. A SUBSEQUENT REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2012 TO REMOVE AND REPLACE ALL COMPONENTS WITH CEMENT SPACERS DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379577 CERAMIC OPTION TYPE 1 TAPER SLEEVE -3 PROSTHESIS, HIP LZO BIOMET ORTHOPEDICS N/A 556630

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R