MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMISTEM-P STD STEM SIZE 1; HIP STEM

Catalog Number	01.18.401
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	05/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Hip revision due to stem loosening.The head and stem have been revised successfully.Primary surgery date is unknown.
Additional Manufacturer Narrative
Batch review performed on 27 may 2024: lot 2103838: (b)(4) items manufactured and released on 19-jul-2021.Expiration date: 2026-06-27.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 medacta medical affairs manager: revision surgery due to stem loosening.From the radiographic images signs of stress shielding are visible.The stem mobilized because no sufficient primary stability was found and as a consequence the leg shortned and there was no osteointegration.Aseptic loosening is a possible literature described adverse event after primary hip arthroplasties and causes are often unknown.The reason of this failure cannot be determined.Investigation performed by medacta hip r&d project manager: during the analysis 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.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.
Additional Manufacturer Narrative
Information reported in this follow up: - piece returned on the (b)(6) 2024.

• Brand Name: AMISTEM-P STD STEM SIZE 1
• 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: 19566893
• Report Number: 3005180920-2024-00424
• Device Sequence Number: 17934003
• Product Code: LZO
• UDI-Device Identifier: 07630040720007
• UDI-Public: 07630040720007
• 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 Explanted Year: 2024
• 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): 09/10/2024

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: 06/27/2026
• Device Catalogue Number: 01.18.401
• Device Lot Number: 2103838
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2021
• 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: Female