MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MINIMAX STEMS; MINIMAX CEMENTLESS ANATOMICAL STEM LEFT SIZE 5

Model Number	01.13.105L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09 june 2025.(b)(4) items manufactured and released on 24-jun-2020.Expiration date: 2025-06-08.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 medacta medical affairs manager: a revision surgery was performed approximately four years after the primary total hip arthroplasty due to shortening of the operated leg, associated with pain and limping.It was reported that the patient began experiencing these symptoms immediately after the primary procedure.The underlying cause was identified as an intraoperative fracture of the greater trochanter, which had been managed with cerclage wiring.Pre-revision radiographic images demonstrated bone remodeling around the greater trochanter, with evidence of partial bone resorption.Intraoperative femoral fractures are recognized complications of total hip arthroplasty, well-documented in the scientific literature.Their occurrence is primarily related to patient-specific factors, such as bone morphology and mechanical properties.In this case, there is no evidence to suggest any malfunction or defect of the implanted device.The available pictures clearly show successful osseointegration of the stem.Visual inspection performed by medacta hip r&d project mananger: looking at the stem body some opaque white spots are visible on 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.Additionally some parts of patient bone residuals are present close to the stem body.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.Root cause: based on the information available no definitive root cause can be established, while there is no indication that any potential issue with the device may have caused or contributed to the event, and the investigation does not indicate any potential manufacturing related issue.
Event or Problem Description
During the primary total hip arthroplasty (tha) in 2021, the patient sustained a fracture that was treated with cerclage.From the outset, she experienced limping and pain, which eventually led to a revision of the implant at 3 years and 11 months post primary.During the removal, the minimax stem, despite the absence of a large portion of the greater trochanter and the proximal periprosthetic bone, was found to be very stable.It was replaced with a modular m-vizion stem.The acetabular component was left untouched, as it was found to be intact and stable.

• Brand Name: MINIMAX STEMS
• Common Device Name: MINIMAX CEMENTLESS ANATOMICAL STEM LEFT SIZE 5
• 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: 22334724
• Report Number: 3005180920-2025-00588
• Device Sequence Number: 9069742
• Product Code: LZO
• UDI-Device Identifier: 07630030803239
• UDI-Public: 07630030803239
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K170845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 06/26/2025

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: 06/08/2025
• Device Model Number: 01.13.105L
• Device Lot Number: 1910607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2020
• 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