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

Model Number 01.12.035

Device Problem Migration (4003)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/27/2023

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 08-feb-2023: lot 2011443: (b)(4) manufactured and released on 22-feb-2021.Expiration date: 2026-02-04.No anomalies found related to the problem.To date, (b)(4) of the same lot have been sold with no similar reported case during the period of review.Clinical evaluation performed by medacta medical manager: revision 1 month after primary tha on a male patient due to joint luxation.The patient had a primary hip surgery after a fall and consequent femoral bone fracture.From the radiographic image provided, the stem seems undersized and subsided which may have caused the adverse event.The surgery was completed successfully revising the medacta stem and head to a competitor stem and head, and revising the medacta cup and liner with a new medacta cup and liner.There is no reason to suspect a faulty device.

Event Description

On (b)(6) 2022, the patient had a primary hip surgery after a fall and consequent femoral bone fracture.Presently, on (b)(6) 2023, the patient came in reporting a joint luxation.The surgeon noticed that the stem appeared to be undersized and had significant subsidence.The surgery was completed successfully revising the medacta stem and head to a competitor stem and head, and revising the medacta cup and liner with a new medacta cup and liner.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 5
• Type of Device: HIP CEMENTLESS STEM
• 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 16435302
• MDR Text Key: 310141396
• Report Number: 3005180920-2023-00115
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07630030802171
• UDI-Public: 07630030802171
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082792
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/24/2023

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 Model Number: 01.12.035
• Device Catalogue Number: 01.12.035
• Device Lot Number: 2011443
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/30/2023
• Initial Date FDA Received: 02/24/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/22/2021
• 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 Sex: Male