MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 50; CEMENTLESS ACETABULAR SHELL

Catalog Number	01.26.45.0050
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 22-july-2019.Lot 181694: (b)(4) items manufactured and released on 08-june-2018.Expiration date: 2023-05-29.No anomalies found related to the problem to date, 154 items of the same lot have been already sold with another similar reported event.
Event or Problem Description
During the hip replacement surgery, the surgeon decided to open and implant the versafit cc trio cup diam.50 because he used the acetabular reamer diam.50 and the trial cup diam.50.However, when the surgeon was going to impact the final cup, it did not fix correctly in the acetabulum.Therefore, he decided to use the acetabular reamers diam.52 and 54 and he finally implanted the versafit cc trio cup diam.54.

• Brand Name: CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 50
• Common Device Name: CEMENTLESS ACETABULAR SHELL
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 8844857
• Report Number: 3005180920-2019-00658
• Device Sequence Number: 2499179
• Product Code: LZO
• UDI-Device Identifier: 07630030807763
• UDI-Public: 07630030807763
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/11/2019

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: 05/29/2023
• Device Catalogue Number: 01.26.45.0050
• Device Lot Number: 181694
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2019
• Initial Report FDA Received Date: 07/31/2019
• 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