BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H HA COATED LAT STEM SIZE 3

    MDR report key: 10507114 · Received September 9, 2020

    Report

    Report Number
    3005180920-2020-00584
    Event Type
    Injury
    Date Received
    September 9, 2020
    Date of Event
    August 10, 2020
    Report Date
    September 9, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804199
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 20-AUG-2020: LOT 103236: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-NOV-2010. EXPIRATION DATE: 31.10.2015. 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 SINCE 2016. ADDITIONAL IMPLANT INVOLVED: BALL HEADS: COCR 01.25.012 COCR BALL HEAD 12/14 Ø 28 SIZE M 0 (K072857) LOT. 132343. BATCH REVIEW PERFORMED ON 09-SEP-2020: LOT 132343: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-JUL-2013. EXPIRATION DATE: 31-MAY-2018. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT SINCE 2016. ADDITIONAL IMPLANT INVOLVED: LINER: VERSAFITCUP DM 01.26.2860MHC DOUBLE MOBILITY HC LINER Ø 60/28 (K092265) LOT. 114609. BATCH REVIEW PERFORMED ON 09-SEP-2020: LOT 114609: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-FEB-2012. EXPIRATION DATE: 31-JAN-2017. 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 SINCE 2016.

    Description of Event or Problem · 1

    THE PATIENT CAME IN REPORTING DISCOMFORT 6 YEARS AND 8 MONTHS AFTER THE PRIMARY. THE CAUSE OF THE DISCOMFORT IS UNKNOWN. THE SURGEON REVISED THE STEM, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    973967 STEM: AMISTEM H HA COATED LAT STEM SIZE 3 CEMENTLESS HIP STEM LZO MEDACTA INTERNATIONAL SA 01.18.143 103236 07630030804199

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention