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

Model Number	01.18.143
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	03/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 5 years and 5 months after primary, the patient has been revised because of stem loosening.The stem was not osteointegrated and was removed by hand during the revision.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 10-mar-2025.Lot 1901588: (b)(4) items manufactured and released on 29-may-2019.Expiration date: 19-may-2024.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: a revision surgery was performed approximately five and a half years after the implantation of a total hip arthroplasty due to stem loosening.Available x-ray images clearly confirm signs of stem mobilization and subsidence.Aseptic loosening is a well-documented complication following primary cementless hip arthroplasties, though its exact causes often remain unclear.In this case, we do not have sufficient information for determinig the reason for the failure.Visual inspection: looking at the stem body some spots of white film are visible on stem body.It is not possible to identify if this film is ha or bone residual, or a combined effect.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.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.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 FEMORAL STEMS
• Common Device Name: AMISTEM H CEMENTLESS STEM LATERALIZED 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: 21771466
• Report Number: 3005180920-2025-00232
• Device Sequence Number: 12820924
• Product Code: LZO
• UDI-Device Identifier: 07630030804199
• UDI-Public: 07630030804199
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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
• Report Date (Section B): 04/04/2025

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: 05/19/2024
• Device Model Number: 01.18.143
• Device Lot Number: 1901588
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2024
• Initial Report FDA Received Date: 04/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2019
• 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: 68 YR
• Patient Sex: Male
• Patient Race: White