MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 1; HIP CEMENTLESS STEM

Model Number 01.12.021

Device Problems Fracture (1260); Appropriate Term/Code Not Available (3191)

Patient Problem Hip Fracture (2349)

Event Date 11/24/2020

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 04 december 2020 lot 2005134: 54 items manufactured and released on 24-sep-2020.Expiration date: 2025-09-21.No anomalies found related to the problem.To date, 16 items of the same lot have been already sold without any other similar reported event.Clinical evaluation few days after primary cementless tha, the patient fell and got a periprosthetic fracture, which required exchange of the femoral stem and head.No reason to suspect that a faulty device originated this complication.

Event Description

The patient was operated 15 days after primary due to a periprostehtical fracture which extended from the calcar down to the minor trochanter.The surgeon doesn't know if the fracture was done during the primary surgery on (b)(6) 2020 or if it is due the fact that the patient fell.The was exchanged with a new quadra stem size 3 and the bone got a cerclage, ceramic head was revised as well.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 1
• Type of Device: HIP CEMENTLESS STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 11043167
• MDR Text Key: 222619338
• Report Number: 3005180920-2020-00931
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07630030802027
• UDI-Public: 07630030802027
• Combination Product (y/n): Y
• Reporter Country Code: SZ
• PMA/PMN Number: K082792
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 01.12.021
• Device Catalogue Number: 01.12.021
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/24/2020
• Initial Date FDA Received: 12/20/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/24/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention