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

Catalog Number 01.26.48MB

Device Problem Unintended Movement (3026)

Patient Problem Pain (1994)

Event Date 09/24/2019

Event Type  Injury  

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 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
• 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, switzerland 6874 ; SZ 6874
• MDR Report Key: 9233157
• MDR Text Key: 176281107
• Report Number: 3005180920-2019-00893
• 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: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/11/2021
• Device Catalogue Number: 01.26.48MB
• Device Lot Number: 155352
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2016
• 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