MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP CC TRIO ACETABULAR SYSTEM; LINER: VERSAFITCUP CC TRIO 01.26.3244HCT FLAT PE HC LINER Ø32/E

Model Number	01.26.3244HCT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 10-04-2025 lot 2429321: (b)(4) items manufactured and released on 27-11-2024.Expiration date: 2029-11-14.No anomalies found related to the problem.To date, (b)(4) item of the same lot has been sold with no similar reported event during the period of review.Other device involved: cup: versafitcup cc trio 01.26.45.1150 versafitcup metalback cc trio no-hole ø50 mm (k122911) lot 2430697: (b)(4) items manufactured and released on 07-01-2025.Expiration date: 2029-12-16.No anomalies found related to the problem.To date, 20 item of the same lot has been sold with no similar reported event during the period of review.Visual inspection performed by r&d manager: from the received part, no visible or particular defects were noticed.In addition, a functional test was done, in order to evaluate the liner insertion.An impaction test was performed with an acetabular shell versafitcup cc trio size 50, compatible with the liner: the liner resulted totally inserted after few strikes without any issue.From this evaluation we cannot determine the root cause of the event, since the liner correctly inserted during the functional test; however, a probable cause could be related to an improper alignment with the shell and/or the presence of liquid or tissue still inside the shell.Based on the information available no definitive root cause can be established.Returned devices were performed with positive results, failure of coupling intraoperatively could be due to the presence of liquid or tissue inside the shell.There is no indication that any potential issue with the device may have caused or contributed to the event, and the device history record review does not indicate any potential manufacturing related issue.
Event or Problem Description
During surgery the surgeon could not couple the liner with the cup.After multiple attempts a new implant was opened which clipped successfully.30 minutes of delay were reported.

• Brand Name: VERSAFITCUP CC TRIO ACETABULAR SYSTEM
• Common Device Name: LINER: VERSAFITCUP CC TRIO 01.26.3244HCT FLAT PE HC LINER Ø32/E
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 21975575
• Report Number: 3005180920-2025-00351
• Device Sequence Number: 18454791
• Product Code: LZO
• UDI-Device Identifier: 07630030807572
• UDI-Public: 07630030807572
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/07/2025

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 Model Number: 01.26.3244HCT
• Device Lot Number: 2429321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 05/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown