BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACETABULAR CUP

    MDR report key: 9365819 · Received November 22, 2019

    Report

    Report Number
    3010536692-2019-01152
    Event Type
    Injury
    Date Received
    November 22, 2019
    Date of Event
    February 1, 2013
    Report Date
    December 29, 2020
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    HWT
    UDI-DI
    M684PHA062201
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 10/09/2020, UPDATED PATIENT AGE, INCIDENT DESCRIPTION, LOT NUMBER, INITIAL REPORTER INFORMATION AND INVESTIGATION CODES.

    Additional Manufacturer Narrative · 0

    UPDATE INITIAL REPORTER INFORMATION.

    Description of Event or Problem · 0

    (B)(4). ALLEGEDLY, REVISION SURGERY OF THE LEFT HIP DUE TO EARLY PROCOTYL L CUP LOOSENING AND MIGRATION. REMOVAL OF LOOSED ACETABULAR COMPONENT (PROCOTYL L), THREADED CUP IMPLANTATION, REPLACEMENT OF MODULAR NECK AND HEAD (DUE TO INFECTION RISK REDUCTION). ADDITIONAL INFORMATION RECEIVED ON 10/09/2020 FROM CLINICAL DEPARTMENT : ADDING LOT NUMBERS OF THE PRODUCTS , UPDATING CUSTOMER AND DOCTOR INFORMATION.

    Additional Manufacturer Narrative · 1

    THIS EVENT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    (B)(4). ALLEGEDLY, REVISION SURGERY OF THE LEFT HIP DUE TO EARLY PROCOTYL L CUP LOOSENING AND MIGRATION. REMOVAL OF LOOSED ACETABULAR COMPONENT (PROCOTYL L), THREADED CUP IMPLANTATION, REPLACEMENT OF MODULAR NECK AND HEAD (DUE TO INFECTION RISK REDUCTION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1158777 ACETABULAR CUP HIP COMPONENT HWT MICROPORT ORTHOPEDICS INC. PHA06220 1101243604 M684PHA062201

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention