BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS REINFORCED YOKE

    MDR report key: 3843971 · Received June 2, 2014

    Report

    Report Number
    0001825034-2014-05130
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 7, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KRO
    PMA / PMN Number
    PK052685
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, 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 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 10 OF 12 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2014-05121/05132).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT AN ORTHOPEDIC SALVAGE SYSTEM PROCEDURE ON (B)(6) 2014. SUBSEQUENTLY, PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2014 DUE TO INFECTION. DURING THE REVISION PROCEDURE, ALL COMPONENTS WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321160 OSS REINFORCED YOKE PROSTHESIS, HIP KRO BIOMET ORTHOPEDICS N/A 106750

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R