MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM-P STD STEM SIZE 5; HIP CEMENTLESS STEM

Catalog Number	01.18.405
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	03/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 29 march 2021: lot 1908269: (b)(4) items manufactured and released on 04-mar-2020.Expiration date: 2025-02-23.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.
Event or Problem Description
When the patient was being moved after the primary hip surgery and was getting up from a sitting position, the patient sustained a fracture and subsided stem.The fracture caused the subsided stem.The surgeon decided to revise the stem, head, and liner 4 days after primary.The surgery was completed successfully.

• Brand Name: AMISTEM-P STD STEM SIZE 5
• Common Device Name: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11700207
• Report Number: 3005180920-2021-00314
• Device Sequence Number: 3500113
• Product Code: LZO
• UDI-Device Identifier: 07630040720045
• UDI-Public: 07630040720045
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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): 04/21/2021

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: 02/23/2025
• Device Catalogue Number: 01.18.405
• Device Lot Number: 1908269
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2021
• Initial Report FDA Received Date: 04/21/2021
• 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