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

Catalog Number	01.18.402
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	02/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 19 february 2020: lot 1904135: (b)(4) items manufactured and released on 05-sep-2019.Expiration date: 2024-08-20.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 medical affairs manager: few days 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.There is no reason to suspect a faulty device preliminary investigation performed by r&d project manager.Based on the image received, it is not possible to determine an implant related failure root cause.
Event or Problem Description
Revision surgery performed one week after the primary surgery, due to femoral fracture.The surgeon decided to use a stapping to contain the fracture, no implant revised.The surgery was completed successfully.The reason for the fracture is unknown.

• Brand Name: STEM: AMISTEM P AMISTEM-P STD STEM SIZE 2
• Common Device Name: CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9799437
• Report Number: 3005180920-2020-00134
• Device Sequence Number: 16304446
• Product Code: LZO
• UDI-Device Identifier: 07630040720014
• UDI-Public: 07630040720014
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/06/2020

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: 08/20/2024
• Device Catalogue Number: 01.18.402
• Device Lot Number: 1904135
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2020
• Initial Report FDA Received Date: 03/06/2020
• 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: 70 YR
• Patient Weight: 50