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

Model Number	01.18.404
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 2 months from primary the patient came in reporting pain due to a subsided stem and the cause is reported to be an undersized stem.The surgeon revised the medacta stem and head with medacta components and revised the medacta liner and cup with competitor components.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 14-jan-2024.Lot 2340482: (b)(4) items manufactured and released on 04-03-2024.Expiration date: 2029-02-18.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.Based on the information available no definitive root cause can be established.Information received report that the cause of the subsidence could be an undersized stem although this could not be confirmed.The device history record review does not indicate any potential manufacturing related issue and there is no indication that any potential issue with the device may have caused or contributed to the event.

• Brand Name: AMISTEM-P
• Common Device Name: AMISTEM-P STD STEM SIZE 4
• 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: 21354288
• Report Number: 3005180920-2025-00025
• Device Sequence Number: 15690958
• Product Code: LPH
• UDI-Device Identifier: 07630040720038
• UDI-Public: 07630040720038
• 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: 2025
• 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): 02/11/2025

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 Lot Number: 2340482
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2025
• Initial Report FDA Received Date: 02/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/04/2024
• 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
• Patient Race: White