MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM-H HA COATED STD STEM SIZE 3; CEMENTLESS HIP STEM

Model Number 01.18.133

Device Problem Insufficient Information (3190)

Patient Problem Hip Fracture (2349)

Event Date 11/30/2017

Event Type  Injury  

Manufacturer Narrative

Clinical evaluation performed by medical affairs director on 22 december 2017: partial hip revision surgery (stem and head) occurred 3 days after primary implantation due to a calcar fracture.This event may be due to the normal intraoperative bone weakening caused by the femoral preparation and may have occurred after weight bearing during the immediate postoperative rehabilitation period.There is no reason to suspect a faulty device.Batch review performed on 29 december 2017 lot 170813: (b)(4) items manufactured and released on 07 june 2017.Expiration date: 2022-05-25.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.

Event Description

The patient came in complaining of pain.The surgeon determined the patient had a calcar fracture.The cause of the fracture is unknown.

• Brand Name: AMISTEM-H HA COATED STD STEM SIZE 3
• Type of Device: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7153830
• MDR Text Key: 96006811
• Report Number: 3005180920-2017-00794
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630030804090
• UDI-Public: 07630030804090
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093944
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/25/2022
• Device Model Number: 01.18.133
• Device Lot Number: 170813
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/30/2017
• Initial Date FDA Received: 12/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention