BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OXFORD KEEL BLD STK HUB

    MDR report key: 3772994 · Received April 25, 2014

    Report

    Report Number
    0001825034-2014-03284
    Event Type
    Injury
    Date Received
    April 25, 2014
    Date of Event
    March 25, 2014
    Report Date
    March 31, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HXZ
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 RECEIVING CERTIFICATE OF CONFORMANCE SHOWED THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT LEFT PARTIAL KNEE ARTHROPLASTY ON (B)(6) 2014. DURING THE PROCEDURE, A STERILE BLADE THAT WAS EXPIRED WAS USED. THE SURGERY WAS COMPLETED WITHOUT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251610 OXFORD KEEL BLD STK HUB CUTTER, WIRE HXZ BIOMET ORTHOPEDICS N/A 985223

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R