BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMAX CEMENTLESS ANATOMICAL STEM RIGHT SIZE 3 L

    MDR report key: 7344708 · Received March 16, 2018

    Report

    Report Number
    3005180920-2018-00157
    Event Type
    Injury
    Date Received
    March 16, 2018
    Date of Event
    January 30, 2018
    Report Date
    February 16, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030803208
    PMA / PMN Number
    K170845
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 14 MARCH 2018; LOT 169044: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24 MAY 2017. EXPIRATION DATE:2022-05-07 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. MPACT DOUBLE MOBILITY HC LINER 28/DMG REFERENCE 01.26.2854MHC (K092265); LOT 163188: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12 SEPTEMBER 2016. EXPIRATION DATE: 2021-08-23 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 M 0 REFERENCE 01.29.202 (K112115); LOT 172250: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28 AUGUST 2017 EXPIRATION DATE:2022-08-20 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. THE PATHOGEN IS UNKNOWN. THE SURGEON WASHED OUT THE HIP AND REVISED THE STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188805 MINIMAX CEMENTLESS ANATOMICAL STEM RIGHT SIZE 3 L CEMENTLESS ANATOMICAL STEM LZO MEDACTA INTERNATIONAL SA 169044 07630030803208

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention