MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H FEMORAL STEMS; AMISTEM H 0HA COATED LAT STEM SIZE 4

Model Number	01.18.144
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	01/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 8 years and 5 months after primary, the patient has been revised because of stem loosening.Stem, ball head and liner revised successfully.
Additional Manufacturer Narrative
Batch review performed on 30-jan-2025: (b)(4) items manufactured and released on 18-sep-2015.Expiration date: 08-sep-2020.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation performed by clinical affairs department.A revision surgery was performed approximately nine years after the primary total hip arthroplasty due to stem loosening.The available x-ray image is of poor quality; however, radiolucencies appear to be present at the middle-proximal stem level, along with cortical thickening distally, possibly as a response to proximal loosening.Aseptic loosening is a known complication of primary cementless hip arthroplasties, with causes often remaining unclear.In this case, the exact reason for failure cannot be definitively determined.Preliminary investigation performed by r&d department.From the images attached to the complaint the following explanted implants are visible: stem: in the images the proximal half of the explanted stem is visible, the stem is covered with patient blood.Looking at the stem body an opaque white film is visible on approximately half of the stem length.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.A lot of signs of 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.Liner and femoral head: in the images the explanted liner and femoral head are visible.Some signs of minor damage and scratches are present and the liner is connected with a screw, 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.

• Brand Name: AMISTEM H FEMORAL STEMS
• Common Device Name: AMISTEM H 0HA COATED LAT STEM SIZE 4
• 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: 21354695
• Report Number: 3005180920-2025-00074
• Device Sequence Number: 12721555
• Product Code: MEH
• UDI-Device Identifier: 07630030804205
• UDI-Public: 07630030804205
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/11/2025

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: 09/08/2020
• Device Model Number: 01.18.144
• Device Lot Number: 151454
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 02/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/18/2015
• 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: 85 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White