BEUDAMED
    FDA Adverse Event Other Summary report: N

    PINN MAR +4 10D 36IDX52OD

    MDR report key: 2051482 · Received March 4, 2011

    Report

    Report Number
    1818910-2011-03469
    Event Type
    Other
    Date Received
    March 4, 2011
    Date of Event
    February 3, 2011
    Report Date
    October 16, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    K033273
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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

    THE PATIENT WAS FIRST REVISED TO ADDRESS A FRACTURED LINER; THE SALES REP WAS NOT AWARE OF ANY PREVIOUS REVISIONS. THE PATIENT WAS THEN REVISED TO ADDRESS PAIN CAUSED BY CUP MALPOSITIONING AND THE SUBSEQUENT METAL WEAR. IT WAS STATED IN THE REPORTING THAT THE CUP WAS VERY VERTICAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINN MAR +4 10D 36IDX52OD 87LPH LPH DEPUY ORTHOPAEDICS, INC. NA BJ3BT1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NA.