BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM-P COLLARED AMISTEM-P COLLARED STD STEM 2

    MDR report key: 12877898 · Received November 26, 2021

    Report

    Report Number
    3005180920-2021-00922
    Event Type
    Injury
    Date Received
    November 26, 2021
    Date of Event
    October 29, 2021
    Report Date
    November 26, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040720212
    PMA / PMN Number
    K173794
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 2 NOVEMBER 2021. LOT 2000071: (B)(4). EXPIRATION DATE: 2025-MAY-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (B)(4). ADDITIONAL ITEMS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 02 NOVEMBER 2021 LINER: VERSAFITCUP DM 01.26.2848MHC DOUBLE MOBILITY HC LINER Ø 48/28 (K092265) LOT. 2103095. LOT 2103095: (B)(4). EXPIRATION DATE: 2026-APR-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (B)(4). BALL HEADS: MECTACER 01.29.201 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE S -3.5 (K112115) LOT. 2101448. LOT 2101448: (B)(4). EXPIRATION DATE: 2026-MAY-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (B)(4).

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING PAIN DUE TO A POTTED STEM AND DUE TO SIGNS OF AN INFECTION. THE CAUSE OF THE POTTED STEM IS INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 2 WEEKS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE STEM, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1776248 STEM: AMISTEM-P COLLARED AMISTEM-P COLLARED STD STEM 2 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 01.18.432 2000071 07630040720212

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention