MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 54

Catalog Number 01.26.45.0054

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/22/2018

Event Type  malfunction  

Manufacturer Narrative

Batch review performed on 10 april 2018.Lot 174454: (b)(4) items manufactured and released on 10 october 2017.Expiration date: 2022-11-01.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold with a similar reported event visual inspection performed on 16 april 2018 by (b)(4) product manager: from visual inspection, the acetabular cup polar threaded hole shows signs of plastic deformation, a typical result of a non-conform forced insertion of the cup impactor terminal.It is also possible to visualize the alternative thread path.It is possible to deduce that after few impaction events, the cup and the terminal disconnected leaving the cup inside the acetabular region not fully seated.The connection between cup and terminal was then difficult to reach in the following attempts due to the aforementioned reason and the plastic deformation caused by impaction.Acetabular cup taper shows deep scratches due to the extraction process.

Event Description

The terminal cup impactor disconnected from the cup when the surgeon was positioning the cup.They tried again but it disconnected again.Then they used a new cup with the same cup impactor.The terminal cup impactors in the hospital show no damage.No patient harm.

• Brand Name: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 54
• 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, 6874 ; SZ 6874
• MDR Report Key: 7442498
• MDR Text Key: 106632681
• Report Number: 3005180920-2018-00247
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630030807787
• UDI-Public: 07630030807787
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K103352
• 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: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2022
• Device Catalogue Number: 01.26.45.0054
• Device Lot Number: 174454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2017
• 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): Other