MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP ACETABULAR SHELL Ø 54; ACETABULAR SHELL CEMENTLESS

Catalog Number 01.26.54MB

Device Problem Contamination (1120)

Patient Problem Unspecified Infection (1930)

Event Date 04/05/2017

Event Type  Injury  

Manufacturer Narrative

This is the second revision surgery underwent by the patient.The patient had a primary hip surgery in (b)(6) 2011 and the first revision surgery in (b)(6) 2011 (reason for the revision is unknown).The surgeon revised the stem, head and liner.Then, the patient came in again due to signs of infection in (b)(6) 2017.Batch reviews performed on 02 may 2017.(b)(4).

Event Description

The patient came in due to signs of infection.The infection is confirmed.The pathogen is not available.The surgeon revised all hardware and implanted an antibiotic spacer.The surgery was completed successfully x-rays and explants are not available.

• Brand Name: VERSAFITCUP ACETABULAR SHELL Ø 54
• Type of Device: ACETABULAR SHELL CEMENTLESS
• 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, 6874 ; SZ 6874
• MDR Report Key: 6547247
• MDR Text Key: 74513564
• Report Number: 3005180920-2017-00231
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K083116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Catalogue Number: 01.26.54MB
• Device Lot Number: 111939
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/05/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/25/2011
• 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: 72 YR