MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: MINIMAX CEMENTLESS ANATOMICAL STEM RIGHT SIZE 3; CEMENTLESS HIP STEM

Catalog Number	01.13.103R
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs manager: few weeks after cementless total hip arthroplasty, the patient reported pain due to a femoral fracture.During rehabilitation period, a sudden movement on a weakened bone due to normal femoral preparation may favour the occurrence of early fracture.There is no reason to suspect a faulty device.Batch review performed on 06 jun 2019: lot 184063: (b)(4) items manufactured and released on 15-oct-2018.Expiration date: 2023-10-02.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with 2 other similar reported events (complaints (b)(4)).
Event or Problem Description
Revision surgery performed 2 weeks after the primary due to bone fracture and subsided stem.The patient was walking to the bathroom and felt a crack in her hip, could then not weight bare.The mini max stem has been removed, implanted a xacta 37.5mm and a new head, plus 3 cables.

• Brand Name: STEM: MINIMAX CEMENTLESS ANATOMICAL STEM RIGHT SIZE 3
• Common Device Name: CEMENTLESS HIP STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8685954
• Report Number: 3005180920-2019-00450
• Device Sequence Number: 2319470
• Product Code: LZO
• UDI-Device Identifier: 07630030803208
• UDI-Public: 07630030803208
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K170845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/11/2019

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: 10/02/2023
• Device Catalogue Number: 01.13.103R
• Device Lot Number: 184063
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2019
• Initial Report FDA Received Date: 06/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Weight: 50