MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP CC TRIO ACETABULAR SHELL Ø52

Catalog Number 01.26.45.0052

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Joint Disorder (2373)

Event Date 03/20/2017

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 02 may 2017.Lot 134528: (b)(4) items manufactured and released on 27 november 2013.Expiration date: 2018-10-31.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event.Not available.

Event Description

Revision surgery due to aseptic loosening of the cup.The patient had a previous infection due to a previous spine surgery.The surgeon supposed that the previous antibiotic treatment could have damaged the bone and consequently the stability of the cup.

• Brand Name: VERSAFITCUP CC TRIO ACETABULAR SHELL Ø52
• Type of Device: ACETABULAR SHELL
• 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: 6547280
• MDR Text Key: 74512995
• Report Number: 3005180920-2017-00238
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K103352
• 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: 10/31/2018
• Device Catalogue Number: 01.26.45.0052
• Device Lot Number: 134528
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/07/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/27/2013
• 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: 65 YR