MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM-P LAT STEM SIZE 6; HIP CEMENTLESS STEM

Catalog Number	01.18.416
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	11/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
About 1 year and 5 months, the patient was reporting pain and a revision surgery was performed due to stem mobilization.
Additional Manufacturer Narrative
Batch review performed on 22 november 2023: lot 2111619: (b)(4) items manufactured and released on 20-dec-2021.Expiration date: 2026-nov-30.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation performed by medacta clinical manager: revision about 1 year and 5 months after the index surgery due to implant mobilization.The patient reported pain.From the radiographic images it is visible the implant mobilized.With the information at hand it is not possible to determine the cause of the event.However, there is no reason to suspect a faulty device.

• Brand Name: AMISTEM-P LAT STEM SIZE 6
• Common Device Name: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 18354868
• Report Number: 3005180920-2023-00976
• Device Sequence Number: 17744308
• Product Code: LZO
• UDI-Device Identifier: 07630040720151
• UDI-Public: 07630040720151
• 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: 2022
• Device Explanted Year: 2023
• 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): 12/19/2023

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 Catalogue Number: 01.18.416
• Device Lot Number: 2111619
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2023
• Initial Report FDA Received Date: 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/20/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male