MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP CC TRIO ACETABULAR SYSTEM; VERSAFITCUP CC TRIO FLAT PE HC LINER Ø 32 / E

Model Number	01.26.3244HCT
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Visual inspection performed by r&d manager: the components have been visually analyzed on (b)(6)2024.The liner shows signs of wear but no breakage or significant mechanical damages, thus appearing to still preserve its functionality.Some wear of the pe component is visible at the naked eye.Since we do not have radiographs available for further analysis, we cannot determine whether the wear induced osteolysis and whether it may be related to implant malpositioning.The head shows signs of damages on the external surface; therefore, we reserve in-depth analysis in order to determine a possible correlation to the event.Batch review performed on 27 november 2024 lot 100627: (b)(4) items manufactured and released on 20-apr-2010.Expiration date: 2015-02-28.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported events during the period of review.Root cause: there is no indication that any potential issue with the device may have caused or contributed to the event, and the investigation does not indicate any potential manufacturing related issue.
Event or Problem Description
Revision surgery performed at about 14 years 5 months after the primary for unknown reason.The surgeon revised the liner and head.Some wear of the pe component is visible.

• Brand Name: VERSAFITCUP CC TRIO ACETABULAR SYSTEM
• Common Device Name: VERSAFITCUP CC TRIO FLAT PE HC LINER Ø 32 / 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: 20911253
• Report Number: 3005180920-2024-00995
• Device Sequence Number: 12709719
• 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
• Device Implanted Year: 2010
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2015
• Device Model Number: 01.26.3244HCT
• Device Lot Number: 100627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/20/2010
• 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: Required Intervention
• Patient Sex: Unknown