BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIG M PKA GDE/MDL SET MED MP

    MDR report key: 2770554 · Received October 3, 2012

    Report

    Report Number
    0001825034-2012-01817
    Event Type
    Injury
    Date Received
    October 3, 2012
    Date of Event
    August 28, 2012
    Report Date
    September 5, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    NRA
    PMA / PMN Number
    PK110415
    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.

    Additional Manufacturer Narrative · 1

    SUPPLIER MANUFACTURER REVIEWED PLANNING AND PROCEDURES THAT WERE UTILIZED TO MANUFACTURE THE GUIDES. SUPPLIER CONFIRMED THAT THE GUIDES WERE MANUFACTURED ACCORDING TO THE SURGEON'S PREFERENCES. THE ROOT CAUSE OF THE ISSUE COULD NOT BE IDENTIFIED AS THE GUIDES WERE MANUFACTURED ACCORDING TO SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN OXFORD SIGNATURE ARTHROPLASTY ON (B)(6) 2012, THE GUIDES WERE PLACED ON THE PATIENT AND FIT WELL. AFTER THE INITIAL BONE PREPARATION THE FLEXION GAP COULD NOT BE ACCOMMODATED BY THE 9MM BEARING SPACER, THE LEVEL OF RESECTION WAS TOO DEEP. TO COMPLETE THE PROCEDURE THE CASE WAS CONVERTED TO TOTAL KNEE AND A 6MM TIBIAL MEDIAL AUGMENT WAS REQUIRED TO FINISH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIG M PKA GDE/MDL SET MED MP PROSTHESIS, KNEE NRA BIOMET ORTHOPEDICS N/A 058307

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention