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

Catalog Number	01.26.48MB
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 04-oct-2019: lot 155352: 50 items manufactured and released on 22-jun-2016.Expiration date: 11.Jan.2021.No anomalies found related to the problem.To date, all items of the same lot have been already sold without any other similar reported event.Clinical evaluation performed by medical affairs department: revision surgery performed 3, 5 years after cementless double-mobility total hip arthroplasty.In the radiographic image provided the cup looks horizontal and protruded in the pelvis.From this single pre-revision x-ray it is not possible to determine the primary position of the cup.Furthermore, no information concerning patient age and bone quality is available.The reason of this event cannot be determined.
Event or Problem Description
The patient came in complaining of pain and the cause of the pain was a shifted cup post-implantation (after 3 years and 5 months from the primary surgery), the acetabulum wall is not fractured.The surgeon revised the cup and liner and the surgery was completed successfully.

• Brand Name: CUP: VERSAFITCUP ACETABULAR SHELL Ø 48
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9233157
• Report Number: 3005180920-2019-00893
• Device Sequence Number: 2484185
• Product Code: MEH
• UDI-Device Identifier: 07630030808036
• UDI-Public: 07630030808036
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/24/2019

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: 01/11/2021
• Device Catalogue Number: 01.26.48MB
• Device Lot Number: 155352
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2019
• Initial Report FDA Received Date: 10/24/2019
• 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