MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 2, SHORT NECK; UNCEMENTED HIP STEM

Catalog Number 01.12.32SN

Device Problem Fracture (1260)

Patient Problem Hip Fracture (2349)

Event Date 10/08/2019

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 15 october 2019: lot 1901703: 16 items manufactured and released on 29-may-2019.Expiration date: 2024-05-20.No anomalies found related to the problem.To date, 8 items of the same lot have been already sold without any other similar reported event.

Event Description

The patient came in complaining of pain due to a fracture distal to the tip of the stem.The cause of the fracture is unknown.The surgeon cabled the fracture and revised the medacta head and stem with competitor items 3 weeks after primary.The surgery was completed successfully.

• Brand Name: QUADRA-H CEMENTLESS, HA COATED LAT STEM SIZE 2, SHORT NECK
• Type of Device: UNCEMENTED HIP 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: 9283650
• MDR Text Key: 165263413
• Report Number: 3005180920-2019-00939
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07630030802720
• UDI-Public: 07630030802720
• 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: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/06/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 05/20/2024
• Device Catalogue Number: 01.12.32SN
• Device Lot Number: 1901703
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/08/2019
• Initial Date FDA Received: 11/06/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/29/2019
• 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: 79 YR