MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM H FEMORAL STEMS; HIP FEMORAL STEM

Model Number	01.18.134
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	09/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had pain and the surgeon noticed radiolucency around stem component.At about 8 years and 10 months post primary the surgeon revised the stem, head and liner.The surgeon toke 15 minutes to remove the stem from the femur.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 27 september 2024 lot 152525: (b)(4) items manufactured and released on 14-sep-2015.Expiration date: 2020-08-07.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 department.A revision surgery was performed about 8 years and 10 months after the primary implantation of a total hip arthroplasty (tha).The revision was prompted by pain and the presence of radiolucent lines around the stem.Pre-revision x-rays confirmed the radiolucency, particularly around the shoulder of the stem.This finding, along with the patient's reported pain, suggests possible stem loosening, although it was noted that stem removal was not so easy.Radiolucency lines and aseptic loosening are known adverse event documented in the literature for primary cementless hip arthroplasties, with its causes often remaining unclear.The exact reason for this failure could not be definitively determined.

• Brand Name: AMISTEM H FEMORAL STEMS
• Common Device Name: HIP FEMORAL STEM
• 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: 20406386
• Report Number: 3005180920-2024-00791
• Device Sequence Number: 3579384
• Product Code: LZO
• UDI-Device Identifier: 07630030804106
• UDI-Public: 07630030804106
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K093944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2024
• 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): 10/09/2024

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: 08/07/2020
• Device Model Number: 01.18.134
• Device Lot Number: 152525
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2024
• Initial Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/14/2015
• 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 Sex: Male
• Patient Race: White