BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT ACETABULAR SHELL Ø48 TWO-HOLE

    MDR report key: 8054893 · Received November 9, 2018

    Report

    Report Number
    3005180920-2018-00867
    Event Type
    Injury
    Date Received
    November 9, 2018
    Date of Event
    October 10, 2018
    Report Date
    November 9, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810732
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 09 NOVEMBER 2018. LOT 157817: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22 APRIL 2016. EXPIRATION DATE: 2021-01-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED ON OCTOBER 26, 2018 BY MEDICAL AFFAIRS DIRECTOR: TWO YEARS AFTER PRIMARY CEMENTLESS THA THE PATIENT LAMENTS ANTERIOR HIP PAIN AND THE SURGEON DECIDES TO CHANGE THE CUP POSITION. THE PRE-REVISION RADIOGRAPHS CONFIRM THAT THE CUP POSITION (LIMITED ANTEVERSION, PARTICULARLY) MAY BE THE CAUSE OF PAIN. IT IS POSSIBLE THAT THE CUP MOBILIZED SLIGHTLY IMMEDIATELY AFTER PRIMARY SURGERY, BECAUSE IT WAS FOUND TO BE SOLIDLY INGROWN AT 2 YEARS. THIS PROBLEM SHOULD NOT BE ASCRIBED TO A DEFECT INTRINSIC TO THE DEVICE. PRELIMINARY INVESTIGATION PERFORMED ON NOVEMBER 09, 2018 BY R&D PRODUCT MANAGER: THE IMAGES SHOW THE CUP JUST EXPLANTED WITH BLOOD AND BIOLOGICAL TISSUE ON ITS SURFACE. FROM THE IMAGES IT IS NOT POSSIBLE TO DETERMINE ANY ROOT CAUSE RELATED TO THE EVENT BUT, FROM THE RECEIVED INFORMATION AND IMAGES WE CAN PROBABLY EXCLUDE A FAILURE OF THE DEVICE.

    Description of Event or Problem · 1

    ABOUT 2 YEARS AND 3 MONTHS AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR A PROBABLE EARLY POST PRIMARY MOBILIZATION OF THE CUP SUCCESSIVELY BECOME VERY SOLID WITH PLENTY OF BONY IN-GROWTH. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    894752 MPACT ACETABULAR SHELL Ø48 TWO-HOLE ACETABULAR SHELL LPH MEDACTA INTERNATIONAL SA 157817 07630030810732

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention