BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPACT FLAT PE HC LINER Ø32/D

    MDR report key: 7008637 · Received November 8, 2017

    Report

    Report Number
    3005180920-2017-00637
    Event Type
    Injury
    Date Received
    November 8, 2017
    Date of Event
    October 9, 2017
    Report Date
    November 8, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030811876
    PMA / PMN Number
    K103721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEWS PERFORMED ON 06 NOVEMBER 2017. LOT 168466: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07 MARCH 2017. EXPIRATION DATE: 2022-02-13. 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. MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE S -4, CODE 01.29.204, LOT. 172255 (K112115) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31 JULY 2017. EXPIRATION DATE: 2022-07-19. 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 DUE TO SIGNS OF INFECTION. PATHOGEN WAS CONFIRMED AS SERRATIA.THE LINER AND THE HEAD WERE EXPLANTED AND REPLACED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788202 MPACT FLAT PE HC LINER Ø32/D FLAT PE LINER LPH MEDACTA INTERNATIONAL SA 168466 07630030811876

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention