BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER, ACETABULAR, FMP NEUTRAL 32XMP7 CM

    MDR report key: 10614470 · Received October 1, 2020

    Report

    Report Number
    1644408-2016-00351
    Event Type
    Injury
    Date Received
    October 1, 2020
    Report Date
    September 30, 2020
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: ORIGINAL INITIAL REPORT WAS SUBMITTED AS FOLLOW UP IN ERROR.

    Description of Event or Problem · 1

    REVISION SURGERY - DUE TO THE 35 MM X 8 DEGREE OSTEOIMPLANT TECHNOLOGIES, INC. (OTI) MODULAR NECK BREAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1081624 LINER, ACETABULAR, FMP NEUTRAL 32XMP7 CM LPH 960071

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R