BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMISTEM H HA COATED STD STEM SIZE 1

    MDR report key: 7292101 · Received February 23, 2018

    Report

    Report Number
    3005180920-2018-00093
    Event Type
    Injury
    Date Received
    February 23, 2018
    Date of Event
    January 25, 2018
    Report Date
    February 23, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804076
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 19 FEBRUARY 2018: LOT 156225: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09 FEBRUARY 2016. EXPIRATION DATE: 2021-01-27. NO ANOMALIES FOUND RELATED TO THE ISSUE. 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 M 0 REFERENCE 01.29.205 (K112115) LOT 171408: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09 JUNE 2017. EXPIRATION DATE: 2022-05-25. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. MPACT ACETABULAR SHELL Ø48 TWO-HOLES REFERENCE 01.32.148DH (K132879) LOT 156591: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03 MARCH 2016. EXPIRATION DATE: 2021-02-23. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. MPACT FLAT PE HC LINER Ø32/C REFERENCE 01.32.3239HCT (K103721) LOT 148745: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25 FEBRUARY 2015. EXPIRATION DATE: 2020-01-31. NO ANOMALIES FOUND RELATED TO THE ISSUE. 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 HAD A PRIMARY HIP ON (B)(6) 2016. ON (B)(6) 2017 THE PATIENT HAD THE HEAD REVISED DUE TO INFECTION (B)(4). THE PATIENT CAME IN DUE TO SIGNS OF INFECTION IN 2018. THE PATHOGEN IS CONFIRMED AS (B)(6). ON (B)(6) 2018 THE PATIENT HAD ALL HARDWARE REMOVED AND A SPACER WAS IMPLANTED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136077 AMISTEM H HA COATED STD STEM SIZE 1 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 156225 07630030804076

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention