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

Model Number	01.18.413
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	09/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery performed about 3 years and 10 months after the primary surgery due to stem loosening.Stem and head revised.
Additional Manufacturer Narrative
Batch review performed on 6 september 2024 lot 2005822: (b)(4) items manufactured and released on 12-oct-2020.Expiration date: 2025-sep-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.

• Brand Name: AMISTEM-P
• 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: 20366840
• Report Number: 3005180920-2024-00780
• Device Sequence Number: 17092741
• Product Code: LZO
• UDI-Device Identifier: 07630040720120
• UDI-Public: 07630040720120
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 10/04/2024

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 Expiration Date: 09/30/2025
• Device Model Number: 01.18.413
• Device Lot Number: 2005822
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 10/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/12/2020
• 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 Age: 77 YR
• Patient Sex: Male