MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP DOUBLE MOBILITY HC LINER Ø 56/28; DOUBLE MOBILITY LINER

Catalog Number 01.26.2856MHC

Device Problem Contamination (1120)

Patient Problem Unspecified Infection (1930)

Event Date 05/08/2017

Event Type  Injury  

Manufacturer Narrative

Batch reviews performed on (b)(6) 2017.Lot 160254: (b)(4) items manufactured and released on 08 april 2016.Expiration date: 2021-03-28.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without and this is the second similar event reported on this lot.Mectacer biolox delta ceramic ball head 12/14 ø 28 size m 0, code 01.29.202, lot.165365 (k112115).(b)(4) items manufactured and released on 23 november 2016.Expiration date: 2021-11-14.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Not available.

Event Description

The patient came in due to signs of infection.The pathogen is unknown.The surgeon revised the head and liner.The surgery was completed successfully.X-rays and explants are not available.

• Brand Name: VERSAFITCUP DOUBLE MOBILITY HC LINER Ø 56/28
• Type of Device: DOUBLE MOBILITY LINER
• 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: 6619870
• MDR Text Key: 76942556
• Report Number: 3005180920-2017-00284
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092265
• 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: 06/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2021
• Device Catalogue Number: 01.26.2856MHC
• Device Lot Number: 160254
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/08/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/08/2016
• 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