MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM- P SHORT NECK STD STEM SIZE 2; HIP FEMORAL STEM

Catalog Number	01.18.462
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 june 2024 lot 2318418: (b)(4) items manufactured and released on 08-nov-2023.Expiration date: 2028-10-21.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Clinical evaluation performed by medical affairs department: hip revision 21 days after primary surgery due to periprosthetic fracture.According to report the fracture was caused by stem subsidence.From the radiographic images the stem appears undersized and in valgus position.This may have induced the surgeon to accept a smaller size but the initial stability was not sufficient when loading was applied.There is no reason to suspect a malfunctioning device.
Event or Problem Description
Hip revision due to periprosthetic fracture that was caused by stem subsidence at 21 days from primary surgery.The stem implanted was undersized.Patient's bone quality weak.The surgeon revised successfully the stem and head.

• Brand Name: STEM: AMISTEM- P SHORT NECK STD STEM SIZE 2
• Common Device Name: HIP FEMORAL 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: 19573046
• Report Number: 3005180920-2024-00452
• Device Sequence Number: 4160645
• Product Code: LZO
• UDI-Device Identifier: 07630971243668
• UDI-Public: 07630971243668
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K192126
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 06/20/2024

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: 01.18.462
• Device Lot Number: 2318418
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2024
• Initial Report FDA Received Date: 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/08/2023
• 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
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian