MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP ACETABULAR SHELL Ø 52

Catalog Number	01.26.52MB
Health Effect - Clinical Codes	Irritation (1941); Pain (1994)
Date of Event	12/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 january 2019.Lot 145338: (b)(4) items manufactured and released on 11 november 2014.Expiration date: 2019-09-30.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any similar reported event.Clinical evaluation performed by medical affairs director on january 04, 2019.4 years after primary cementless tha the cup is revised due to psoas impingement, according to report.This problem was not caused by a faulty device.
Event or Problem Description
The patient had pain caused by irritation of the psoas tendon.The surgeon revised the head with a medacta head.The cup and the liner were revised with another company product.The surgery was completed successfully.

• Brand Name: VERSAFITCUP ACETABULAR SHELL Ø 52
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8260590
• Report Number: 3005180920-2018-01108
• Device Sequence Number: 2081665
• Product Code: MEH
• UDI-Device Identifier: 07630030808098
• UDI-Public: 07630030808098
• 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: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/18/2019

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: 09/30/2019
• Device Catalogue Number: 01.26.52MB
• Device Lot Number: 145338
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/18/2019
• 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