BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRX NEUT 36IDX58OD

    MDR report key: 1192013 · Received October 6, 2008

    Report

    Report Number
    1818910-2008-04336
    Event Type
    Injury
    Date Received
    October 6, 2008
    Date of Event
    September 8, 2008
    Report Date
    September 8, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    K072963
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION WAS NOT POSSIBLE, AS THE DEVICE WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT CODE SINCE ITS RELEASE FOR DISTRIBUTION. IT HAS BEEN REPORTED THAT THE DEPUY DEVICE WAS IMPLANTED WITH A COMPETITOR MANUFACTURED PRODUCT. THIS USE OF THE DEPUY DEVICE IS NOT RECOMMENDED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT ERROR WITH REGARD TO THE REPORTED EVENT. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THIS INVESTIGATION CLOSED. SHOULD THE PRODUCT OR ADDITIONAL INFO THAT CHANGES THIS CONCLUSION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    PATIENT REVISED TO ADDRESS DISLOCATION BETWEEN LINER AND COMPETITORS HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRX NEUT 36IDX58OD 87LPH LPH DEPUY ORTHOPAEDICS, INC. NA B6AHG1000

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention