MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM-P; AMISTEM P STD. SIZE 4

Model Number	01.18.404
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	04/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 2 weeks after primary, the patient has been revised because of proximal femoral bone fracture, following inappropriate work with the physiotherapist.Surgery completed successfully.
Additional Manufacturer Narrative
Clinical evaluation performed by medacta medical affairs manager: an early revision surgery was performed a few days after the primary total hip arthroplasty due to stem subsidence and a periprosthetic femoral fracture.The reported cause of failure was inappropriate postoperative physiotherapy.The available x-ray images clearly confirm both the stem subsidence and the femoral fracture.In the early postoperative period, following femoral preparation, the bone is typically weakened, which may have contributed to the failure[?]especially in the context of improper rehabilitation.There is no evidence to suggest a defect in the implanted device.Batch review performed on 14-apr-2025: lot 2341030: (b)(4) items manufactured and released on 31-jan-2024 expiration date: 17-jan-2029.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.Based on the information available no definitive root cause can be established, although it is likely that the suboptimal rehabilitation contributed to the event because, in the early postoperative period, the bone is typically weakened, which may have contributed to the failure.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.
Additional Manufacturer Narrative
Visual inspection: the body of the explanted stem is still fully covered with ha, evidence that the stem has been implanted for such a short time.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.Additional information reported in the follow-up: - date of receipt of the device.- device evaluation.

• Brand Name: AMISTEM-P
• Common Device Name: AMISTEM P STD. 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: 21974578
• Report Number: 3005180920-2025-00361
• Device Sequence Number: 21150832
• Product Code: LZO
• UDI-Device Identifier: 07630040720038
• UDI-Public: 07630040720038
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2025

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 Model Number: 01.18.404
• Device Lot Number: 2341030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Race: White