MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H FEMORAL STEMS; AMISTEM-H STD. SIZE 2

Model Number	01.18.132
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 11 years and 8 months after primary, the patient came in reporting pain due to a potted stem and the cause is unknown.The surgeon revised the stem and head.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 17-apr-2025.(b)(4) items manufactured and released on 29-may-2013.Expiration date: 30-apr-2018.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.

• Brand Name: AMISTEM H FEMORAL STEMS
• Common Device Name: AMISTEM-H STD. SIZE 2
• 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: 21968714
• Report Number: 3005180920-2025-00385
• Device Sequence Number: 8503352
• Product Code: MEH
• UDI-Device Identifier: 07630030804083
• UDI-Public: 07630030804083
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2025
• 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): 05/06/2025

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 Expiration Date: 04/30/2018
• Device Model Number: 01.18.132
• Device Lot Number: 131154
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2025
• Initial Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/29/2013
• 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: Unknown