BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIM-LOCK BIOLOX DELTA CERAMIC LINER

    MDR report key: 6121755 · Received November 22, 2016

    Report

    Report Number
    3010536692-2016-01457
    Event Type
    Injury
    Date Received
    November 22, 2016
    Report Date
    October 24, 2016
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    MRA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ALLEGEDLY REVISED DUE TO DISLOCATION SUBLUXATION. AGE AT PRIMARY: (B)(6), SIDE: L, PRIMARY ASA: P2-MILD DISEASE NOT INCAPACITATING, REVISION NJR INDEX NO: (B)(6), SEX: M, PRIMARY BMI: (B)(6). ADDITIONAL INFORMATION RECEIVED 10/25/2016. ADDED COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771747 RIM-LOCK BIOLOX DELTA CERAMIC LINER HIP COMPONENT MRA MICROPORT ORTHOPEDICS INC. 1245

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention