BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOL 8.0 FULL PC 12/14

    MDR report key: 239938 · Received September 16, 1999

    Report

    Report Number
    1818910-1999-00138
    Event Type
    Injury
    Date Received
    September 16, 1999
    Report Date
    September 16, 1999
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A BROKEN STERN WAS SENT TO THE MANUFACTURER. THE CO'S ONLY INFO SO FAR IS THAT THE STERN WAS MANUFACTURED 8-14-98 AND WAS RECEIVED BY DR. THE DISTAL PORTION OF THE STERN IS STUCK IN A 2422-51-000 REAMER; ALSO RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOL 8.0 FULL PC 12/14 TOTAL HIP PROSTHESIS LPH DEPUY ORTHOPAEDICS, INC. NA S2HAV1

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention