BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE PS FEM TRIAL SZ 3 LT

    MDR report key: 3113801 · Received May 15, 2013

    Report

    Report Number
    1818910-2013-17135
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 7, 2013
    Manufacturer
    1818910 DEPUY ORTHOPAEDICS, INC.
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT ASSOCIATED WITH THIS REPORTED EVENT WAS NOT RETURNED FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY MANUFACTURING DEVIATIONS OR ANOMALIES. X-RAYS WERE NOT AVAILABLE FOR REVIEW. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH (B)(4) APPENDIX A. NO ADDITIONAL INFORMATION WAS OBTAINED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT WITHOUT THE INSTRUMENT TO EXAMINE AND INSUFFICIENT INFORMATION. NO EVIDENCE WAS FOUND SUGGESTING PRODUCT ERROR WAS A CONTRIBUTING FACTOR AND THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    UPON TRIALING OF ATTUNE PS FEMUR, IT WAS NOTICED THAT THE PATIENT'S LATERAL FEMORAL CONDYLE HAD FRACTURED. THE FRACTURE EXTENDED FROM THE ANTERIOR LATERAL PIN HOLE TO THE NOTCH AND THROUGH THE CONDYLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214016 ATTUNE PS FEM TRIAL SZ 3 LT KNEE INSTRUMENT LXH 1818910 DEPUY ORTHOPAEDICS, INC. MVMBAF160

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention