BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT ACETABULAR SHELL Ø 52 TWO-HOLES

    MDR report key: 5615000 · Received April 28, 2016

    Report

    Report Number
    3005180920-2016-00190
    Event Type
    Injury
    Date Received
    April 28, 2016
    Date of Event
    March 29, 2016
    Report Date
    July 22, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 27 JUNE 2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT. ON 30 JUNE 2016 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Additional Manufacturer Narrative · 1

    ON 08 APRIL 2016 THE MEDICAL AFFAIRS DIRECTOR PERFORMED THE FOLLOWING ANALYSIS: CUP REVISION AT TWO WEEKS DUE TO SEVERE MIGRATION OF THE COMPONENT. POST-PRIMARY XRAYS ARE NOT AVAILABLE, NOR ARE THE PREOPERATIVE XRAYS. THESE MIGHT CLARIFY THAT A PECULIAR ANATOMICAL SITUATION REQUIRED THE CUP TO BE IMPLANTED IN A PARTICULAR WAY OR FACING UNUSUAL DIFFICULTIES, BUT THEY ARE NOT AVAILABLE. THE CUP WAS ORIGINALLY IMPLANTED VIOLATING THE MEDIAL ACETABULAR WALL, ACCORDING TO XRAYS, AND CHANCES THAT IT COULD FUNCTION PROPERLY WERE MINIMAL. THE ROOT CAUSE FOR THE REVISION IS CUP MIGRATION DUE TO INAPPROPRIATE POSITIONING. CAUSE FOR INAPPROPRIATE POSITIONING IS NOT KNOWN. BATCH REVIEW PERFORMED ON 27 APRIL 2016. LOT 155990: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22 FEBRUARY 2016. EXPIRATION DATE: 2021-02-03. 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. COCR BALL HEAD 12/14 Ø 36 SIZE XL +7, CODE 01.25.033, LOT. 140058 (K080885) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06 MAY 2014. EXPIRATION DATE: 2019-03-31. 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.

    Description of Event or Problem · 1

    THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON REVISED THE CUP AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS ARE AVAILABLE. EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272475 MPACT ACETABULAR SHELL Ø 52 TWO-HOLES CEMENTLESS ACETABULAR SHELL LPH MEDACTA INTERNATIONAL SA 155990

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention