MAUDE Adverse Event Report: Medacta International SA AMIStem H Femoral Stems; AMIStem-H Std. size 8

Model Number	01.18.138
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Implant Pain (4561); Aseptic loosening (4883)
Date of Event	08/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 11 years and 8 months from the primary, the patient came in presenting pain due to a loose stem and the cause is unknown.The surgeon revised the medacta stem and head to a competitor stem and head, and revised the versafitcup dm liner hc 54/28 to a double mobility hc liner d 28/dmg.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 27 august 2026 stem: amistem h 01.18.138 amistem-h std.Size 8 (k093944) lot 141473: (b)(4)items manufactured and released on 10-jul-2014.Expiration date: 31-may-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 approximately 11 years and 8 months after primary cementless tha, the patient presented with pain associated with aseptic loosening of the femoral stem, with no reported traumatic event.The available radiograph shows marked proximal femoral bone rarefaction, particularly in the trochanteric region, together with an apparent distal fixation pattern (“potting”).This configuration is compatible with progressive proximal stress shielding and loss of proximal bone support, while the stem remained preferentially engaged distally.Such progressive bone remodeling may contribute to altered load transfer and eventual loss of stable fixation over a prolonged period.Aseptic stem loosening is a well-documented complication of cementless tha and is generally multifactorial.Based on the available radiographic and clinical information, the exact cause of the loosening cannot be determined with certainty.No device was available for direct investigation, and there are no elements suggesting a defective or malfunctioning device.Root cause:aseptic loosening is a possible adverse event described in the literature following primary joint arthroplasty, and its causes are often unknown or multifactorial.There is no indication that any potential issue with the device may have caused or contributed to the event, and the investigation does not indicate any potentially related manufacturing issue or systemic deficiency.

• Brand Name: AMIStem H Femoral Stems
• Common Device Name: AMIStem-H Std. size 8
• 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: 50692311
• Report Number: 3005180920-2026-00935
• Device Sequence Number: 13160552
• Product Code: LZO
• UDI-Device Identifier: 07630030804144
• UDI-Public: 07630030804144
• Combination Product (Y/N): N
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/09/2026

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: 05/31/2019
• Device Model Number: 01.18.138
• Device Lot Number: 141473
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2014
• 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: 59 YR
• Patient Sex: Male
• Patient Weight: 159 LB
• Patient Race: White