BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN MAR NEUT 58ODX32ID

    MDR report key: 1983439 · Received January 31, 2011

    Report

    Report Number
    1818910-2011-00978
    Event Type
    Injury
    Date Received
    January 31, 2011
    Date of Event
    December 16, 2010
    Report Date
    March 6, 2026
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    K983014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THERE IS NO NEW INFORMATION TO REPORT AT THIS TIME. PER FDA REQUEST, THIS FOLLOW-UP 1 IS BEING SUBMITTED TO FILL THE GAP IN REPORT SEQUENCE NUMBERS.

    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

    REVISION ON (B)(6) 2010. INLAY WAS TILT MEDIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35477 PINN MAR NEUT 58ODX32ID 87LPH LPH DEPUY ORTHOPAEDICS, INC. NA EY2HT1000

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention