MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 3; HIP CEMENTLESS STEM

Catalog Number 01.12.023

Device Problems Loose or Intermittent Connection (1371); Appropriate Term/Code Not Available (3191)

Patient Problem Joint Disorder (2373)

Event Date 11/28/2019

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 29 november 2019: lot 132658: 60 items manufactured and released on 13-sep-2013.Expiration date: 2018-08-31.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any other similar reported event.

Event Description

The stem and the head were removed due to loosening and replaced with competitor items almost 5 years and 9 months after primary.The surgery was completed successfully.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 3
• 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: 9464997
• MDR Text Key: 185726273
• Report Number: 3005180920-2019-01078
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07630030802041
• UDI-Public: 07630030802041
• 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: 12/13/2019

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: 08/31/2018
• Device Catalogue Number: 01.12.023
• Device Lot Number: 132658
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/27/2019
• Initial Date FDA Received: 12/13/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/13/2013
• 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: 58 YR