MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM-P COLLARED; AMISTEM-P COLLARED STD. SIZE 5

Model Number	01.18.435
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	08/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 25-08-2025.Lot 186910: (b)(4) items manufactured and released on 29-10-2018 expiration date: 2023-10-18.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.Aseptic loosening is a possible literature-described adverse event after primary hip arthroplasties and causes are often unknown.There is no indication that any potential issue with the device may have caused or contributed to the event.No previous case has been addressed to a device design or manufacturing related root cause.
Event or Problem Description
At about 6 years and 7 months from primary, the patient came in reporting pain due to a loose femoral component and the cause is unknown.The surgeon revised the medacta stem and head with competitor components and revised the medacta liner with a medacta liner.The surgery was complete successfully.

• Brand Name: AMISTEM-P COLLARED
• Common Device Name: AMISTEM-P COLLARED STD. SIZE 5
• 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: 23081548
• Report Number: 3005180920-2025-00849
• Device Sequence Number: 15968756
• Product Code: LZO
• UDI-Device Identifier: 07630040720243
• UDI-Public: 07630040720243
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 09/18/2025

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: 10/18/2023
• Device Model Number: 01.18.435
• Device Lot Number: 186910
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/29/2018
• 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: Male
• Patient Race: Black Or African American