MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP DOUBLE MOBILITY LINER Ø 54/28

Catalog Number 01.26.2854M

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Joint Disorder (2373)

Event Date 10/16/2017

Event Type  Injury  

Manufacturer Narrative

Batch reviews performed on 13 november 2017.Lot 110327: (b)(4) items manufactured and released on 24 march 2011.Expiration date: 2016-02-29.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.Mectacer biolox forte ceramic ball head 12/14 ø 28 size m 0, code 38.39.7175.255.00, lot.104432 (k073337) (b)(4) items manufactured and released on 18 january 2011.Expiration date: 2015-12-31.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event.

Event Description

The patient came in complaining of a leg length discrepancy.The surgeon revised the head and liner.The surgery was completed successfully.

• Brand Name: VERSAFITCUP DOUBLE MOBILITY LINER Ø 54/28
• 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: 7032801
• MDR Text Key: 92057141
• Report Number: 3005180920-2017-00660
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 07630030807374
• UDI-Public: 07630030807374
• 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
• Report Date: 11/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2016
• Device Catalogue Number: 01.26.2854M
• Device Lot Number: 110327
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/16/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/24/2011
• 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