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

Catalog Number	01.26.45.0048
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot 176622: (b)(4) items manufactured and released on 12-february-2018.Expiration date: 2023-02-01.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Instrument involved: amis cup impactor terminal-m10 reference (b)(4).Lot 1755174: (b)(4) items manufactured and released 25-january-2018.No anomalies found related to the issue.To date, no similar event on the same lot has been registered.
Event or Problem Description
The cup loosened from the terminal during the implant repositioning.The surgeon noticed that the cup thread was damaged.A new cup was implanted successfully.
Additional Manufacturer Narrative
Visual inspection performed by r&d product manager on 23 july 2018.The analysis has been conducted both with the pieces available and images attached to this complaint.During the analysis it is evaluated that the threaded part of the terminal is scratched.In addition also the threaded part of the implant hole is broken.It seem that the user has not completed the screwing of the terminal inside the cup before proceeding with the impaction phase and this caused extra stress on the threaded part causing the fracture.

• Brand Name: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 48
• Common Device Name: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7540703
• Report Number: 3005180920-2018-00363
• Device Sequence Number: 274764
• Product Code: LZO
• UDI-Device Identifier: 07630030807756
• UDI-Public: 07630030807756
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup,Followup
• Report Date (Section B): 07/25/2018

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: 02/01/2023
• Device Catalogue Number: 01.26.45.0048
• Device Lot Number: 176622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2018
• Supplement Date Received by Manufacturer: 04/24/2018; 04/24/2018
• Initial Report FDA Received Date: 05/24/2018
• Supplement Report FDA Received Date: 07/20/2018; 07/25/2018
• 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