BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRX +4 NEUT 36IDX52OD

    MDR report key: 3252972 · Received July 29, 2013

    Report

    Report Number
    1818910-2013-22379
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    November 20, 2012
    Report Date
    July 11, 2013
    Manufacturer
    DEPUY-RAYNHAM, A DIV. OF DEPUY ¿ REG. # 1219655
    Product Code
    LPH
    PMA / PMN Number
    PK062148
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    ATTORNEY

    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 DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS SINCE ITS RELEASE FOR DISTRIBUTION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED.DEPUY CONSIDERS THE INVESTIGATION CLOSED. 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

    PATIENT IS SEEKING LEGAL ACTION. PPD WAS RECEIVED ALONG WITH MEDICAL RECORDS, WHICH INDICATE THAT PATIENT WAS REVISED TO ADDRESS DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353008 ALTRX +4 NEUT 36IDX52OD POLY LINER LPH DEPUY-RAYNHAM, A DIV. OF DEPUY ¿ REG. # 1219655 282593

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention