MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H IMPLANTS; AMISTEM-H STD. 1

Model Number	01.18.131
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	10/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 october 2025.Stem: amistem h 01.18.131 amistem-h std.Size 1 (k093944) lot146948: (b)(4) items manufactured and released on08-jan-2015.Expiration date: 30-nov-2019.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.Clinical evaluation performed by clinical affairs manager.Ten yers after primary cementless tha, the patient' s bone has deformed progressivley and the stem is no longer well fixed.There are some signs of heterotopic ossification around the joint.The patient developed abnormal bone reaction and the shape of the femur changed over time, making the stem no longer suitable for this patient in terms of size and shape.Root cause: 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
After10 years and 6 month from the primary, the patient came in reporting pain due to a potted stem and the cause is unknown.The surgeon revised the medacta stem and head with a competitor stem and head and revised the medacta liner with a new medacta liner.The surgery was completed successfully.

• Brand Name: AMISTEM H IMPLANTS
• Common Device Name: AMISTEM-H STD. 1
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro 6874 ; SZ 6874
• MDR Report Key: 23477197
• Report Number: 3005180920-2025-01078
• Device Sequence Number: 10227747
• Product Code: LZO
• UDI-Device Identifier: 07630030804076
• UDI-Public: 07630030804076
• Combination Product (Y/N): N
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/05/2025

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: 11/30/2019
• Device Model Number: 01.18.131
• Device Lot Number: 146948
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2015
• 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: 73 YR
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Race: White