BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM BIPOLAR SHELL/XLPE LINER 42MM OD 26MM ID

    MDR report key: 6055425 · Received October 25, 2016

    Report

    Report Number
    1020279-2016-00821
    Event Type
    Injury
    Date Received
    October 25, 2016
    Date of Event
    October 7, 2016
    Report Date
    October 7, 2016
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER INDICATED THAT THERE IS NO PRODUCT/DEVICE TO BE RETURNED FOR INVESTIGATION ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED A REVISION SURGERY WAS PERFORMED DUE TO DISASSOCIATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705491 TANDEM BIPOLAR SHELL/XLPE LINER 42MM OD 26MM ID PROSTHESIS, HIP, HEMI-, TRUNNION-BEARING, FEMORAL, METAL/POLYACETAL JDH SMITH & NEPHEW, INC. 15LM13009

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R