MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP ACETABULAR SHELL Ø 54

Catalog Number	01.26.54MB
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	04/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information received on 016 april 2018 the case was completed on (b)(4) 2018.The cup became loose as the cup didn't adhere to the bone.The patient has a history of smoking and cancer which may have caused the lack of adherence.The surgeon revised the cup, liner and head.The surgery was completed successfully.Clinical evaluation performed by medical affairs director on (b)(4) 2018: smoke is a factor that can cause lack of osseointegration.Batch review performed on 02 may 2018.Lot 157614:60 items manufactured and released on 22 march 2016.Expiration date: 2021-03-08.No anomalies found related to the problem.To date, 57 items of the same lot have been already sold without any similar reported event.
Event or Problem Description
Revision surgery after 1 year and 10 months from the primary due to cup loosening.

• Brand Name: VERSAFITCUP ACETABULAR SHELL Ø 54
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7479653
• Report Number: 3005180920-2018-00288
• Device Sequence Number: 13879341
• Product Code: MEH
• UDI-Device Identifier: 07630030808128
• UDI-Public: 07630030808128
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K083116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/08/2021
• Device Catalogue Number: 01.26.54MB
• Device Lot Number: 157614
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2018
• Initial Report FDA Received Date: 05/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention