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

Model Number	01.18.142
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	01/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery due to aseptic stem loosening about 5 years and 10 months after the primary surgery.Stem, head, and liner revised.
Additional Manufacturer Narrative
Batch review performed on 30 january 2026.Lot 152218a: (b)(4) item manufactured and released on 17-jun-2019.Expiration date: 26-may-2024.No anomalies found related to the problem.This is a resterilized lot.Original lot: lot 152218: (b)(4) items manufactured and released on 14-jul-2015.Expiration date:30-jun-2020.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.Clinical evaluation: about 5 years and 10 months after primary cementless tha, the stem is radiographically loose and needs exchanging.We have been supplied only one radiograph, taken at revision, so we cannot evaluate the history and the onset of the loosening, nor can we evaluate the appropriate stem sizing at the time of primary.With the information at hand, we must include this event among the idiopathic aseptic loosening cases.R&d analysis: from the information and the image available it is visible the expianted stem covered with patient blood.It is not possible to identify if ha coating or bone residuals are present on the stem body.Some signs and scratches are visible on the neck part probably due to revision surgery.It is not possible to define the root cause for the stem loosening.Root cause:aseptic loosening is a possible literature-described adverse event after primary joint 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.

• Brand Name: AMISTEM H FEMORAL STEMS
• Common Device Name: AMISTEM-H LAT. SIZE 2
• 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: 24429837
• Report Number: 3005180920-2026-00097
• Device Sequence Number: 21406855
• Product Code: LZO
• UDI-Device Identifier: 07630030804182
• UDI-Public: 07630030804182
• Combination Product (Y/N): N
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2026
• 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): 02/24/2026

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: 05/26/2024
• Device Model Number: 01.18.142
• Device Lot Number: 152218A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2019
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 81 KG
• Patient Race: White