MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP CC TRIO ACETABULAR SYSTEM; VERSAFITCUP METALBACK CC TRIO Ø42 MM

Model Number	01.26.45.0042
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	06/10/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 06 july 2026 01.26.45.0042 versafitcup metalback cc trio d 42 mm (k122911) lot.2314893: (b)(4) items manufactured and released on 29 november 2023.Expiration date: 13 november 2028.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Visual inspection visual inspection performed on 6 july 2026.No evident signs or defects were noticed; the liner was still inside the shell, while the coating appeared totally absorbed.From the received information and components, the root cause of the event is unknown but there is no evidence of a failure device.Clinical evaluation a few months after primary cementless tha, the cup migrates decisively in the cranial-medial direction.The post-primary xrays were not supplied, so we cannot tell if the medial wall of the acetabulum had been violated at index surgery, but this is rather possible.With no primary stability achieved, the cup could never be stable and never started the osseointegration phase.This is not due to a device defect or malfunction.Root cause: based on the information available, the cup loosening appears related to lack of primary stability after the index surgery, preventing proper osseointegration.Although this cannot be confirmed without post-primary x-rays, possible medial acetabular wall violation cannot be excluded.The batch review and visual inspection did not indicate any related manufacturing issue, device defect, or malfunction.
Event or Problem Description
Revision surgery after 6 months from primary surgery due to the loosening of the cup.The surgery was successfully completed.

• Brand Name: VERSAFITCUP CC TRIO ACETABULAR SYSTEM
• Common Device Name: VERSAFITCUP METALBACK CC TRIO Ø42 MM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro 6874 ; SZ 6874
• MDR Report Key: 25744802
• Report Number: 3005180920-2026-00625
• Device Sequence Number: 15974107
• Product Code: LZO
• UDI-Device Identifier: 07630030807725
• UDI-Public: 07630030807725
• Combination Product (Y/N): N
• PMA/510(K) Number: K122911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/08/2026

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 Model Number: 01.26.45.0042
• Device Lot Number: 2314893
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2026
• Initial Report FDA Received Date: 07/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2023
• 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: Male
• Patient Race: White