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

Catalog Number	01.18.405
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	08/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27 august 2024 lot 2307222: (b)(4) items manufactured and released on 20-jul-2023.Expiration date: 2028-jul-03.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with 1 similar reported event during the period of review.Please note that the previous case was trauma-related.Clinical evaluation performed by clinical affairs department a revision surgery was performed one month after the primary total hip arthroplasty (tha) due to a periprosthetic fracture.The patient reported pain despite no report of history of trauma.The available x-ray images clearly show a periprosthetic fracture likely involving the entire stem, along with possible subsidence of the stem, which also appears slightly tilted.Determining the exact cause of the issue is challenging: the subsidence may have occurred first due to slight undersizing and a lack of primary stability, potentially leading to the fracture.Based on the available information, no evidence suggests a defective or malfunctioning device.
Event or Problem Description
Revision surgery performed about 1 month after the primary surgery due to femoral bone fracture (fracture at the level of the tip).Stem and head revised.M-vizion stem implanted.

• Brand Name: STEM: AMISTEM P AMISTEM-P STD STEM SIZE 5
• Common Device Name: HIP FEMORAL HEAD
• 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: 20301657
• Report Number: 3005180920-2024-00741
• Device Sequence Number: 12659640
• Product Code: LZO
• UDI-Device Identifier: 07630040720045
• UDI-Public: 07630040720045
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173794
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2024

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: 01.18.405
• Device Lot Number: 2307222
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2024
• Initial Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/09/2024
• 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