MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM-P STD STEM SIZE 5; HIP STEM

Catalog Number	01.18.405
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 10 months after primary, revision surgery performed following stem subsidence due to periprosthetic bone fracture detected by x-rays that showed a vertical bone fracture ryme.All components revised to m-vizion.Patient's bone quality normal.
Additional Manufacturer Narrative
Batch review performed on 31 july 2024.Lot 2308190: (b)(4) items manufactured and released on 18-july-2023.Expiration date: 2028-06-26.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event during the period of review.Visual inspection performed by r&d project manager.During the analysis looking at the stem body an opaque white film is visible on approximately whole of the stem length.It is assumable that these are ha residuals due to the few days of implantation.Not absorption of ha from the stem body can indicate that metabolic activity wasn't taking place and that, presumably, not 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.Clinical evaluation performed by medical affiars director a revision surgery was performed ten months after the primary impantation of a tha.The reported reason for the revison was stem subsidence.It was also reported that the surgeon identified a fracture line on the femur.We have no information about the clinical status of the patient or any history of trauma.Pre-revision x-ray images confirm the subsidence of the stem, but no fracture lines are clearly visible.However, in the lateral projection a periosteal reaction is noticeable, which could indicate a previous fracture in the process of healing.Stem subsidence after a tha is a known complication described in the literature.In this early failure, the lack of ossointegration of the stem, combined with poor bone quality and a possibly low primay stability, may have contributed to the complication.The possible fracture line described is likely a consequence of this stem subsidence.There is no reason to suspect a defective or faulty device.

• Brand Name: AMISTEM-P STD STEM SIZE 5
• Common Device Name: HIP 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: 20035287
• Report Number: 3005180920-2024-00656
• Device Sequence Number: 6404939
• Product Code: LZO
• UDI-Device Identifier: 07630040720045
• UDI-Public: 07630040720045
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 08/22/2024

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 Catalogue Number: 01.18.405
• Device Lot Number: 2308190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2024
• Initial Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2023
• 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: Unknown