MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM P AMISTEM-P STD STEM SIZE 4; HIP STEM CEMENTLESS

Model Number	01.18.404
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	02/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
At 14 days after the primary, the patient came in reporting pain after twisting the leg and breaking the femur just below the tip of the stem.The surgeon revised the stem and head.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 11 february 2022.Lot 2108014: (b)(4) items manufactured and released on 19-oct-2021.Expiration date: 2026-oct-06.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.Clinical evaluation performed by medical affairs director.Few days after primary cementless tha a periprosthetic fracture occurs with no trauma reported.It is conceivable that during surgery, in particular during femoral preparation, the bone may have been weakened and a least-resistance area may have been created.This is a known possible adverse event following tha and there is no reason to suspect that it is due to a defect in the implanted device or in the preparing instruments.

• Brand Name: STEM: AMISTEM P AMISTEM-P STD STEM SIZE 4
• Common Device Name: HIP STEM CEMENTLESS
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 13732016
• Report Number: 3005180920-2022-00165
• Device Sequence Number: 4806648
• Product Code: LZO
• UDI-Device Identifier: 07630040720038
• UDI-Public: 07630040720038
• 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: 2022
• Device Explanted Year: 2022
• 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): 03/11/2022

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 Model Number: 01.18.404
• Device Catalogue Number: 01.18.404
• Device Lot Number: 2108014
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2022
• Initial Report FDA Received Date: 03/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/19/2021
• 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: Female