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

Catalog Number 01.12.023

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

Patient Problem Inadequate Osseointegration (2646)

Event Date 07/02/2019

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 09-07-2019: lot 180844: (b)(4) items manufactured and released on 24-may-2018.Expiration date: 2023-05-14.No anomalies found related to the problem to date, (b)(4) items of the same lot have been already sold without any other similar reported event.Clinical evaluation performed by medical affairs director: revision surgery performed 7 months after cementless total hip arthroplasty.According to the report, histologic sample taken during revision surgery revealed the presence of infection.This is probably the cause or, at least, one of the causes of the stem mobilization.Poor quality of the radiographic image provided does not add any element in order to define the cause of this event.

Event Description

The surgeon performed a revision surgery because the patient had pain at the hip due to proximal loosening around the stem.Since the stem had to be revised, the surgeon also decided to change head and liner 7 months and 10 days after primary.The surgery was completed successfully.

• Brand Name: STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 3
• Type of Device: 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: 8835135
• MDR Text Key: 152472719
• Report Number: 3005180920-2019-00629
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07630030802041
• UDI-Public: 07630030802041
• Combination Product (y/n): N
• 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: 07/29/2019

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: 05/14/2023
• Device Catalogue Number: 01.12.023
• Device Lot Number: 180844
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/02/2019
• Initial Date FDA Received: 07/29/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/24/2018
• 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