MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MINIMAX STEMS; MINIMAX CEMENTLESS ANATOMICAL STEM RIGHT SZE 4

Model Number	01.13.104R
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hip Fracture (2349)
Date of Event	01/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had pain after twisting the hip.No problem with the devices.The femur fractured.At about 3 weeks from primary the surgeon revised the medacta stem and head with competitor components and revised the medacta liner with a medacta liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 07 january 2025: lot 2242470: (b)(4) items manufactured and released on 13-mar-2023.Expiration date: 2028-01-21.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 clinical affairs manager: a revision surgery was performed three weeks after the primary implantation of a total hip arthroplasty (tha).A femoral fracture was reported; however, we have no evidence of this, as the only available x-ray image pertains to the immediate post-operative period.The reported cause of the fracture was a twisting motion of the hip.Unfortunately, we are unable to provide a thorough evaluation, as the available image refers to the post-operative and is of very poor quality, making the bone structures difficult to visualize.

• Brand Name: MINIMAX STEMS
• Common Device Name: MINIMAX CEMENTLESS ANATOMICAL STEM RIGHT SZE 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: 21229329
• Report Number: 3005180920-2025-00003
• Device Sequence Number: 12843422
• Product Code: LZO
• UDI-Device Identifier: 07630030803222
• UDI-Public: 07630030803222
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K170845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 01/24/2025

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: 01.13.104R
• Device Lot Number: 2242470
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/01/2025
• Initial Report FDA Received Date: 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/13/2023
• 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