BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEMORAL AIMER, 7MM OFFSETACL

    MDR report key: 740069 · Received July 19, 2006

    Report

    Report Number
    1221934-2006-00144
    Event Type
    Malfunction
    Date Received
    July 19, 2006
    Date of Event
    July 5, 2006
    Report Date
    July 6, 2006
    Manufacturer
    DEPUY M ITEK
    Product Code
    HRX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NOTHING HAS YET BEEN REC'D FOR ANALYSIS. HOWEVER, WHEN THE COMPLAINT DEVICE IS REC'D, A ROOT CAUSE FAILURE ANALYSIS WILL BE HAD AND THE RESULTS OF THAT INVESTIGATION WILL BE REFLECTED IN A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    OUR REP IS REPORTING THAT DURING TWO KNEE PROCEDURES SOME METAL FILINGS, EITHER FROM THE FEMORAL OFFSET AIMER OR BEING CAUSED BY SOME PHYSICAL ANOMALY OF THE OFFSET AIMER, FELL INTO THE PATIENTS JOINT SPACE. THE DEBRIS WAS SUCTIONED OUT WITH THE AID OF A SHAVER AND THE CASE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER INCIDENT. [PER PHONE CONVERSATION WITH THE REP THERE WAS NO HARM TO THE PT.] [ALSO SEE ASSOCIATED MDR 1221934-2006-00145].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEMORAL AIMER, 7MM OFFSETACL ACL INSTRUMENTS HRX DEPUY M ITEK 219357 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN