MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H FEMORAL STEMS; AMISTEM H CEMENTLESS STEM STANDARD SIZE 3

Model Number	01.18.133
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	07/23/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 30 july 2025 lot 123308: (b)(4) items manufactured and released on 25-oct-2012.Expiration date: 2017-09-30.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported events during the period of review.
Event or Problem Description
Revision at about 9 years and 8 months after primary for stem loosening.
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs department.A revision surgery was performed approximately 10 years after the implantation of a tha.The patient presented with pain and underwent a follow-up x-ray, which revealed evidence of stem loosening.The available imaging clearly confirms this diagnosis, showing radiolucent lines around the stem.Aseptic loosening is a well-documented complication in the literature, often arising from multifactorial or unclear etiologies.In this case as well, the precise cause of failure remains difficult to establish based on the information available.Visual inspection perfformed by r6d project manager.During the analysis it is visible the expianted stem.There are no ha residuals on the stem body.Absorption of ha from the stem body can indicate that metabolic activity was taking place and that, presumably, adequate bone contact was achieved at the time of surgery.The post-op x-ray analysis could possibly provide more insight, such as the evaluation of possible early rotational instability or initial stress-shielding.Some signs of minor damage and scratches are present on the neck of the explanted stem, which is likely due to the revision surgery and not relevant to the reported issue.Based on the analysis completed and information available, it is not possible to identify a root cause of the stem loosening reported.Conclusion: aseptic loosening is a possible literature-described adverse event after primary knee 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 CEMENTLESS STEM STANDARD SIZE 3
• 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: 22781805
• Report Number: 3005180920-2025-00768
• Device Sequence Number: 15485700
• Product Code: LZO
• UDI-Device Identifier: 07630030804090
• UDI-Public: 07630030804090
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2025

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: 09/30/2017
• Device Model Number: 01.18.133
• Device Lot Number: 123308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/12/2025
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2012
• 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: 65 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White