MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM P SHORT NECK STD SIZE 5; FEMOREAL STEM CEMENTLESS

Model Number	01.18.465
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	12/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on (b)(6) 2021: lot 2000108: (b)(4) items manufactured and released on 09-apr-2020.Expiration date: 01-apr-2025.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.Clinical evaluation performed by medacta medical affairs department: few weeks after cementless total hip arthroplasty, the patient reported pain due to a femoral fracture.During rehabilitation period, a sudden movement on a weakened bone due to normal femoral preparation may favour the occurrence of early fracture.Also the presence of an intraoperative fissure, not visible in the immediate postop x-ray, may be a possible cause of this event.There is no reason to suspect a faulty device.
Event or Problem Description
Primary amis surgery was performed on (b)(6) 2020.The patient had pain due to bone fracture.Revision surgery has been scheduled with competitor implants on (b)(6).No additional information is available.

• Brand Name: STEM: AMISTEM P SHORT NECK STD SIZE 5
• Common Device Name: FEMOREAL STEM CEMENTLESS
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11160605
• Report Number: 3005180920-2021-00032
• Device Sequence Number: 3717558
• Product Code: LZO
• UDI-Device Identifier: 07630971243699
• UDI-Public: 07630971243699
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K192126
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/13/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/01/2025
• Device Model Number: 01.18.465
• Device Catalogue Number: 01.18.465
• Device Lot Number: 2000108
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2020
• Initial Report FDA Received Date: 01/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention