MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 5

Model Number 01.12.025

Device Problem Device Slipped (1584)

Patient Problem Hip Fracture (2349)

Event Date 05/13/2020

Event Type  Injury  

Manufacturer Narrative

Batch review performed by medacta regulatory affairs department on 19 may 2020: lot 1900008: (b)(4) items manufactured and released on 29-apr-2019.Expiration date: 14.04.2024.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.

Event Description

The patient dislocated in the hospital and after further investigation with x-ray it was discovered subsidence of the femoral component, the surgeon suspects that during the primary surgery 8 days before occurred a bone fracture, but it is not confirmed if the fracture occurred during of after the primary surgery.The surgeon revised the stem and head and cabled the fracture.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 5
• Type of Device: CEMENTLESS, HA COATED STD STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; CH 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: 10147233
• MDR Text Key: 195584310
• Report Number: 3005180920-2020-00326
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07630030802065
• UDI-Public: 07630030802065
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 06/12/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2024
• Device Model Number: 01.12.025
• Device Catalogue Number: 01.12.025
• Device Lot Number: 1900008
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/13/2020
• Initial Date FDA Received: 06/12/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/29/2019
• 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
• Patient Age: 71 YR