MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: SMS SOLID STEM STD SIZE 13; CEMENTLESS STEM

Model Number	01.36.053
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	03/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 27.04.2021: lot 2001930: (b)(4) items manufactured and released on 22-jun-2020.Expiration date: 2025-06-09.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any other similar reported event.Clinical evaluation performed by medical affairs manager: few days 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.
Event or Problem Description
1 week after the primary surgery the patient came in reporting pain due to a spiral periprosthetic femur fracture which occurred when the patient went to sit down.The surgeon revised the stem and head with competitor products.The surgery was completed successfully.The surgeon did not feel a need to revise the liner.

• Brand Name: STEM: SMS SOLID STEM STD SIZE 13
• Common Device Name: CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11743644
• Report Number: 3005180920-2021-00339
• Device Sequence Number: 14481449
• Product Code: LZO
• UDI-Device Identifier: 07630030888724
• UDI-Public: 07630030888724
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K181693
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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): 04/29/2021

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: 06/09/2025
• Device Model Number: 01.36.053
• Device Catalogue Number: 01.36.053
• Device Lot Number: 2001930
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 04/29/2021
• 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