MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H IMPLANTS; AMISTEM-H STD. 6

Model Number	01.18.136
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	10/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
After 9 years from the primary, the patient came in reporting pain due to a loose 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 medacta liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 20 october 2025.Stem: amistem h 01.18.136 amistem-h std.Size 6 (k093944) lot160645: (b)(4) items manufactured and released on04-may-2016.Expiration date:25-apr-2021.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.9 years after primary cementless tha in a young female patient with very narrow femoral canals, the stem is no longer fixed and becomes painful.It is conceivable that the patient, going through the menopausal period, had some significant changes in her bones and the shape varied over time, making the stem size and shape no longer suited for the new bone.No reason to suspect a defective device at the origin of this revision surgery.Root cause: based on the information available no definitive root cause can be established, while there is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.

• Brand Name: AMISTEM H IMPLANTS
• Common Device Name: AMISTEM-H STD. 6
• 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: 23477190
• Report Number: 3005180920-2025-01077
• Device Sequence Number: 10227743
• Product Code: LZO
• UDI-Device Identifier: 07630030804120
• UDI-Public: 07630030804120
• Combination Product (Y/N): N
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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: 04/25/2021
• Device Model Number: 01.18.136
• Device Lot Number: 160645
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2016
• 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: 50 YR
• Patient Sex: Male
• Patient Race: White