MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MINIMAX STEMS; MINIMAX CEMENTLESS ANATOMICAL STEM RIGHT SIZE 6

Model Number	01.13.106R
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Hip Fracture (2349)
Date of Event	09/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 october 2024: lot 180810: (b)(4) items manufactured and released on 17-may-2018.Expiration date: 2023-05-07.No anomalies found related to the problem.To date, (b)(4) item of the same lot have been sold with no similar reported event during the period of review.Lot 180810a: (b)(4) items manufactured and released on 4-oct-2023.Expiration date: 2028-09-16.No anomalies found related to the problem.To date, (b)(4) item of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation performed by clinical studies department: a revision surgery was performed one month after the primary total hip arthroplasty (tha) due to a periprosthetic fracture.X-ray images confirm the presence of a femoral fracture, and the initial positioning of the femoral stem appears appropriate.While specific details regarding the traumatic nature of the fracture are not provided, periprosthetic fractures are well-documented complications, particularly during the early postoperative period when the bone may be weakened from the surgical preparation of the femur.There is no indication of any device malfunction in this case.
Event or Problem Description
Femur fracture at about 1 month from primary.Head and stem were revised successfully.

• Brand Name: MINIMAX STEMS
• Common Device Name: MINIMAX CEMENTLESS ANATOMICAL STEM RIGHT SIZE 6
• 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: 20470018
• Report Number: 3005180920-2024-00820
• Device Sequence Number: 15333409
• Product Code: LZO
• UDI-Device Identifier: 07630030803260
• UDI-Public: 07630030803260
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K170845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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
• Report Date (Section B): 10/17/2024

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 Model Number: 01.13.106R
• Device Lot Number: 180810A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/04/2023
• 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 Age: 78 YR
• Patient Sex: Male
• Patient Weight: 74 KG