BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT DOUBLE MOBILITY HC LINER Ø 54/28

    MDR report key: 9580570 · Received January 13, 2020

    Report

    Report Number
    3005180920-2019-01141
    Event Type
    Injury
    Date Received
    January 13, 2020
    Date of Event
    December 17, 2019
    Report Date
    January 13, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807381
    PMA / PMN Number
    K092265
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 20 DECEMBER 2019. LOT 1903332: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-JUL-2019. EXPIRATION DATE: 2024-07-08. 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 IMPLANT INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 20 DECEMBER 2019. BALL HEADS: MECTACER 01.29.202 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE M 0 (K112115) LOT. 1903847 LOT 1903847: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-JUL-2019. EXPIRATION DATE: 2024-07-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ONE SIMILAR EVENT REPORTED.

    Description of Event or Problem · 1

    THE PATIENT CAME IN, ONE MONTH AFTER PRIMARY SURGERY, DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46319 LINER: MPACT DOUBLE MOBILITY HC LINER Ø 54/28 DOUBLE MOBILITY HC LINER MEH MEDACTA INTERNATIONAL SA 1903332 07630030807381

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention