MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP ACETABULAR SHELL Ø 48

Catalog Number 01.26.48MB

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Joint Disorder (2373)

Event Date 02/19/2018

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 26 february 2018 lot 154798: (b)(4) items manufactured and released on 03 december 2015.Expiration date: 2020-11-21 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

On (b)(6) 2018 medacta international has been informed by the sales agent that a patient came in complaining of pain.The pain may be attributed to a loose cup.Revision surgery will be necessary.On (b)(6) 2018 surgeon performed the revision surgery.

• Brand Name: VERSAFITCUP ACETABULAR SHELL Ø 48
• 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: 7309092
• MDR Text Key: 101359221
• Report Number: 3005180920-2018-00111
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 07630030808036
• UDI-Public: 07630030808036
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/21/2020
• Device Catalogue Number: 01.26.48MB
• Device Lot Number: 154798
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2015
• 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