BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUMMIT DUOFIX TAP SZ4 STD OFF

    MDR report key: 3012326 · Received March 20, 2013

    Report

    Report Number
    1818910-2013-04279
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    November 20, 2007
    Report Date
    March 27, 2013
    Manufacturer
    DEPUY WARSAW
    Product Code
    LPH
    PMA / PMN Number
    K011489
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICE WAS NOT POSSIBLE AS IT WAS NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER LEG LENGTH DISCREPANCY RELATED REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATION SINCE ITS RELEASE TO DISTRIBUTION. THE INVESTIGATION CAN DRAW NO CONCLUSION WITH THE INFORMATION PROVIDED. IT IS KNOWN THE ASR DEVICES WERE VOLUNTARILY RECALLED FROM THE MARKET. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR FURTHER CORRECTIVE ACTION HAS NOT BEEN INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS LEG LENGTH DISCREPANCY. **UPDATE** 2/20/2013- LITIGATION PAPERS RECEIVED. THE MDR DECISION HAS BEEN REVERSED AND ALL PRODUCTS REPORTED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE INVESTIGATION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116003 SUMMIT DUOFIX TAP SZ4 STD OFF STEM LPH DEPUY WARSAW BN9FG1000

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention