BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: AMISTEM H HA COATED LAT STEM SIZE 8

    MDR report key: 12015240 · Received June 17, 2021

    Report

    Report Number
    3005180920-2021-00491
    Event Type
    Injury
    Date Received
    June 17, 2021
    Date of Event
    May 17, 2021
    Report Date
    June 17, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030804243
    PMA / PMN Number
    K093944
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 27 MAY 2021 LOT 102760: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-SEP-2010. EXPIRATION DATE: 2015-08-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. 1 ITEM RESTERILIZED AND RELEASED ON 24-AUG-2012. EXPIRATION DATE: 2017-06-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (B)(4) RESTERILIZED AND RELEASED ON 13-JUN-2015. EXPIRATION DATE: 2020-04-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (B)(4) RESTERILIZED AND RELEASED ON 06-JUL-2015. EXPIRATION DATE: 2020-05-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (B)(4) RESTERILIZED AND RELEASED ON 05-AUG-2015. EXPIRATION DATE: 2020-05-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (B)(4) RESTERILIZED AND RELEASED ON 24-AUG-2015. EXPIRATION DATE: 2020-07-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (B)(4) RESTERILIZED AND RELEASED ON 23-SEP-2015. EXPIRATION DATE: 2020-08-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (B)(4) RESTERILIZED AND RELEASED ON 18-MAY-2016. EXPIRATION DATE: 2021-05-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT SINCE 2017. CLINICAL EVALAUTION PERFORMED BY MEDICAL AFFAIRS DIRECTOR: PERIPROSTHETIC FRACTURE 2 WEEKS AFTER PRIMARY THA. THE PATIENT SEEMS TO BE OVERWEIGHT AND RATHER OLD, WITH VERY THIN CORTICAL BONE. ON THE OTHER HAND, THE STEM LOOKS UNDERSIZED, AND THE ACETABULAR CUP NOT WELL LAID ON THE MEDIAL WALL, BUT THESE CONDITIONS ARE UNLIKELY TO HAVE CAUSED THE FRACTURE. IN ANY CASE, WE SEE NO REASON TO SUSPECT A FAULTY DEVICE.

    Description of Event or Problem · 1

    THE PATIENT CAME IN 2 WEEKS AFTER PRIMARY FOLLOWING A PERIPROSTHETIC FRACTURE (UNKNOWN CAUSE). THE SURGEON CABLED THE FRACTURE AND REVISED SUCCESSFULLY STEM AND HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    912843 STEM: AMISTEM H HA COATED LAT STEM SIZE 8 HIP CEMENTLESS STEM LZO MEDACTA INTERNATIONAL SA 01.18.148 102760 07630030804243

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention