BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø56

    MDR report key: 6221204 · Received January 4, 2017

    Report

    Report Number
    3005180920-2016-00702
    Event Type
    Injury
    Date Received
    January 4, 2017
    Date of Event
    December 6, 2016
    Report Date
    May 12, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    PMA / PMN Number
    K143453
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 23 DECEMBER 2016 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: EARLY INFECTION IN CEMENTLESS THA FEW WEEKS AFTER PRIMARY. INFECTIONS ARE A KNOWN, POSSIBLE ADVERSE EVENT FOLLOWING THA, DESCRIBED IN LITERATURE. IN THIS CASE, THERE IS NO INDICATION THAT A FAULTY DEVICE ORIGINATED THE PROBLEM. BATCH REVIEWS PERFORMED ON 29 DECEMBER 2016. LOT 161645: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17 JUNE 2016. EXPIRATION DATE: 2021-06-06. 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. MASTERLOC CEMENTLESS TI COATED STEM SIZE 8 LAT, CODE 01.39.208, LOT. 162132 (K151531) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30 MAY 2016. EXPIRATION DATE: 2021-05-18. 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. MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE L +3.5, CODE 01.29.203, LOT. 161742 (K112115) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11 MAY 2016. EXPIRATION DATE: 2021-04-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (b)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD AND THIS IS THE SECOND SIMILAR EVENT REPORTED ON THE SAME LOT (MDR 2016-00631). DOUBLE MOBILITY HC LINER Ø 56/28, CODE 01.26.2856MHC, LOT. 131722 (K092265) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06 JUNE 2013. EXPIRATION DATE: 2018-04-30. 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 13 APRIL 2017 AND INCLUDES: ON (B)(6) 2017 THE SURGEON REMOVED THE SPACER AND IMPLANTED PERMANENT IMPLANTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF INFECTION. THE PATHOGEN WAS CONFIRMED AS SERRATIA MARCESCENS. THE SURGEON REVISED ALL MEDACTA COMPONENTS AND IMPLANT AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS ARE AVAILABLE. EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5381 MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø56 DOUBLE MOBILITY ACETABULAR SHELL LPH MEDACTA INTERNATIONAL SA 161645

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention