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

Catalog Number	01.26.45.0054
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/22/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7442498
• Report Number: 3005180920-2018-00247
• Device Sequence Number: 1976159
• Product Code: LZO
• UDI-Device Identifier: 07630030807787
• UDI-Public: 07630030807787
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2018
• Initial Report FDA Received Date: 04/19/2018
• 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: Other