MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP ACETABULAR SHELL Ø 58; CEMENTLESS ACETABULAR SHELL

Catalog Number 01.26.58MB

Device Problem Device Slipped (1584)

Patient Problems Pain (1994); Joint Disorder (2373)

Event Date 10/26/2017

Event Type  Injury  

Manufacturer Narrative

On 17 november 2017 the medical affairs director performed a clinical evaluation and commented as follows: 4 years after primary cementless tha with double mobility cup the acetabular component was found to be loose and then replaced.The supplied radiograph bears no date and it is possibly referring to early postoperative, before loosening of the cup took place.No specific finding can be observed on this documentation and the reason for loosening remains unknown.Batch review performed on 20 november 2017.(b)(4).To date, all items of the same lot have been already sold without any similar reported event.

Event Description

The patient came in complaining of pain.The surgeon determined the cup was loose.The surgeon revised the cup, the liner and the head.The surgery was completed successfully.

• Brand Name: VERSAFITCUP ACETABULAR SHELL Ø 58
• Type of Device: CEMENTLESS 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: 7057482
• MDR Text Key: 92859033
• Report Number: 3005180920-2017-00699
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 07630030808203
• UDI-Public: 07630030808203
• 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: Other
• Type of Report: Initial
• Report Date: 11/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: 01.26.58MB
• Device Lot Number: 130122
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/26/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/02/2013
• 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
• Patient Age: 73 YR