BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM-P COLLARED AMISTEM-P COLLARED STD STEM SIZE 8

    MDR report key: 11795931 · Received May 10, 2021

    Report

    Report Number
    3005180920-2021-00369
    Event Type
    Injury
    Date Received
    May 10, 2021
    Date of Event
    April 12, 2021
    Report Date
    May 10, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040720274
    PMA / PMN Number
    K173794
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 10 MAY 2021: LOT 186915: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-NOV-2018. EXPIRATION DATE: 2023-11-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL ITEMS INVOLVED IN THE EVENT: LINER: VERSAFITCUP DM 01.26.2854MHC DOUBLE MOBILITY HC LINER Ø 54/28 (K092265) LOT. 2003322. BATCH REVIEW PERFORMED ON 10 MAY 2021: LOT 2003322: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-JUL-2020. EXPIRATION DATE: 2025-07-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. BALL HEADS: MECTACER 01.29.202 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE M 0 (K112115) LOT. 2007621. BATCH REVIEW PERFORMED ON 10 MAY 2021: LOT 2007621: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-OCT-2020. EXPIRATION DATE: 2025-10-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING PAIN AND INSTABILITY DUE TO A LEG LENGTH DISCREPANCY. THE CAUSE OF THE LEG LENGTH DISCREPANCY IS UNKNOWN. THE SURGEON REVISED THE STEM, HEAD AND LINER 3 DAYS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693774 STEM: AMISTEM-P COLLARED AMISTEM-P COLLARED STD STEM SIZE 8 CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 186915 07630040720274

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention