BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRX +4 NEUT 32IDX50OD

    MDR report key: 7800973 · Received August 21, 2018

    Report

    Report Number
    1818910-2018-67237
    Event Type
    Injury
    Date Received
    August 21, 2018
    Report Date
    July 27, 2018
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    UDI-DI
    10603295016281
    PMA / PMN Number
    K062148
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE HISTORY LOT: NULL. DEVICE HISTORY BATCH: NULL. DEVICE HISTORY REVIEW: NULL.

    Description of Event or Problem · 1

    PINNACLE PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES INFECTION AFTER FIRST REVISION. DOI: (B)(6) 2012; DOR: NOT REPORTED; (RIGHT HIP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643158 ALTRX +4 NEUT 32IDX50OD PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS LPH DEPUY ORTHOPAEDICS INC US 273317 10603295016281

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other