BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRX NEUT 32IDX52OD

    MDR report key: 1983403 · Received January 31, 2011

    Report

    Report Number
    1818910-2011-00622
    Event Type
    Injury
    Date Received
    January 31, 2011
    Date of Event
    January 3, 2011
    Report Date
    January 3, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC
    Product Code
    LPH
    PMA / PMN Number
    K072963
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 1

    PT WAS REVISED TO ADDRESS A LINER WHICH WAS LOOSE FROM THE CUP. SOME SOFT TISSUE WAS FOUND BETWEEN THE LINER AND THE CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRX NEUT 32IDX52OD 87LPH LPH DEPUY ORTHOPAEDICS, INC NA EL2JC1000

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention