MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP ACETABULAR SHELL 50 HIP UNCEMENTED SHELL

Model Number 01.26.50MB

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Joint Disorder (2373)

Event Date 06/29/2020

Event Type  Injury  

Manufacturer Narrative

Batch review performed on (b)(6) 2020: lot 133925: 40 items manufactured and released on 24-oct-2013. Expiration date: 2018-09-30. 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 since 2016.

Event Description

The patient came in reporting groin pain due to cup impingement. The surgeon revised the medacta cup and liner with another company's product and revised the medacta head with a medacta head 6 years and 2 months after primary. The surgery was completed successfully.

• Brand Name: VERSAFITCUP ACETABULAR SHELL 50
• Type of Device: HIP UNCEMENTED 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: 10294918
• MDR Text Key: 199537325
• Report Number: 3005180920-2020-00447
• Device Sequence Number: 1
• Product Code: MEH
• 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: 07/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 09/30/2018
• Device Model Number: 01.26.50MB
• Device Catalogue Number: 01.26.50MB
• Device Lot Number: 133925
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/29/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/24/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 07/20/2020 Patient Sequence Number: 1