BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø48

    MDR report key: 7309241 · Received March 2, 2018

    Report

    Report Number
    3005180920-2018-00114
    Event Type
    Injury
    Date Received
    March 2, 2018
    Date of Event
    January 31, 2018
    Report Date
    March 2, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030860959
    PMA / PMN Number
    K143453
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CLINICAL EVALUATION PERFORMED ON 16 FEBRUARY 2018: PARTIAL HIP REVISION SURGERY OCCURRED 1 YEAR AND 3 MONTHS AFTER PRIMARY CEMENTLESS DOUBLE MOBILITY TOTAL HIP ARTHROPLASTY. RADIOGRAPHIC IMAGES PROVIDED ALLOW SUBOPTIMAL EVALUATION OF THE CUP POSITION AND SURROUNDING BONE STATUS. REGIONS OF OSTEOLYSIS ARE VISIBLE IN THE EQUATORIAL REGION BUT PICTURES SHOW THE PRESENCE OF BONE ADHESION ON THE CUP SURFACE. ASEPTIC LOOSENING IS A POSSIBLE LITERATURE DESCRIBED ADVERSE EVENT AFTER PRIMARY CEMENTLESS THA AND REASONS ARE OFTEN UNKNOWN. IN THIS CASE, THE CAUSE OF FAILURE CANNOT BE DETERMINED. BATCH REVIEW PERFORMED ON 26 FEBRUARY 2018 LOT 162385: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24 JUNE 2016. EXPIRATION DATE: 2021-06-15 NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. PRELIMINARY INVESTIGATION PERFORMED BY R&D PRODUCT MANAGER ON 02 MARCH 2018: THE MPACT SHOWN IN THE PICTURES WAS STILL EXPLANTED. THE REASONS OF THE EVENT ARE UNKNOWN AS IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE FROM THE RECEIVED IMAGES.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN 1 YEAR AND 3 MONTHS AFTER PRIMARY. THE CUP WAS LOOSE. THE CAUSE IS UNKNOWN. NO REPORT OF TRAUMA. THE SURGEON REVISED THE CUP, LINER AND HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152566 MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø48 DOUBLE MOBILITY ACETABULAR SHELL LPH MEDACTA INTERNATIONAL SA 162385 07630030860959

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention