MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM P STD SIZE 2; CEMENTLESS FEMORAL STEM

Catalog Number	01.18.402
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	03/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 march 2021: lot 2005836: (b)(4) items manufactured and released on 12-oct-2020.Expiration date: 2025-10-01.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.Clinical evaluation performed by medacta medical affairs department: few days after cementless total hip arthroplasty, the patient reported pain due to a fracture in an elderly lady ((b)(6) year old).During rehabilitation period, a sudden movement on a weakened bone due to normal femoral preparation may favour the occurrence of early fracture.There is no reason to suspect a faulty device.
Event or Problem Description
Revision surgery 1 week after primary surgery.The reason is about 2cm femur spiral fracture on the lesser trochanter and a small fracture on the great trochanter causing stem subsidence.The femur devices have been replaced and the fractures fixed with competitor devices.

• Brand Name: STEM: AMISTEM P STD SIZE 2
• Common Device Name: CEMENTLESS FEMORAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11595555
• Report Number: 3005180920-2021-00259
• Device Sequence Number: 3606225
• Product Code: LZO
• UDI-Device Identifier: 07630040720014
• UDI-Public: 07630040720014
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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): 03/31/2021

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: 10/01/2025
• Device Catalogue Number: 01.18.402
• Device Lot Number: 2005836
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2021
• Initial Report FDA Received Date: 03/31/2021
• 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
• Patient Age: 83 YR
• Patient Weight: 60