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

Catalog Number 01.26.45.0048

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/24/2018

Event Type  malfunction  

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 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.

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
• Type of Device: ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7540703
• MDR Text Key: 109507158
• Report Number: 3005180920-2018-00363
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 07630030807756
• UDI-Public: 07630030807756
• Combination Product (y/n): N
• PMA/PMN Number: K103352
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 07/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 04/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other