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

Catalog Number 01.26.52MB

Device Problems Failure To Adhere Or Bond (1031); Unstable (1667)

Patient Problem No Code Available (3191)

Event Date 08/02/2016

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 31 august 2016.Lot 090243: (b)(4) items manufactured and released on 27 april 2009.Expiration date: 2014-03-31.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.

Event Description

The patient came in complaining of instability.The surgeon noticed that the cup had loosened.The surgeon revised the cup, head and liner.The surgery was completed successfully.X-rays are available.Explants are not available.

Manufacturer Narrative

On 09 september 2016 the (b)(4) performed a clinical evaluation and commented as follows: significant medial migration of a double mobility cementless cup in tha after 7 years.The reasons for migration cannot be determined with the information available.The cup looks slightly oversized, but this is unlikely to have been the main cause for the problem.Cup migration is a possible adverse event following tha.There are no elements to suggest that a faulty device caused this problem.

• Brand Name: VERSAFITCUP 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 ; 91 6966060
• MDR Report Key: 5916987
• MDR Text Key: 53556521
• Report Number: 3005180920-2016-00443
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 10/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2014
• Device Catalogue Number: 01.26.52MB
• Device Lot Number: 090243
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/02/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/27/2009
• 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