MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP CC TRIO ACETABULAR SYSTEM; VERSAFITCUP METALBACK CC TRIO Ø46 MM

Model Number	01.26.45.0046
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Granuloma (1876)
Date of Event	11/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation performed by medacta medical affairs director: about 9 years after primary cementless tha, revision of the acetabular cup is required because of development of bone granuloma, according to report.The etiology of this development is unknown.Nothing in the report or the one image supplied makes us suspect that it could be related to any kind of implant malfunction.Batch review performed on 12 november 2025: lot 164410: (b)(4) items manufactured and released on 4-oct-2016.Expiration date: 2021-sep-21.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.Root cause: based on the information available no definitive root cause can be established, while 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 at about 8 years and 8 months after the primary surgerybecause of development of bone granuloma at acetabulum bone level.The shell was migrated from its original position.The etiology of this development is unknown.No infection detected.

• Brand Name: VERSAFITCUP CC TRIO ACETABULAR SYSTEM
• Common Device Name: VERSAFITCUP METALBACK CC TRIO Ø46 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: 23615704
• Report Number: 3005180920-2025-01158
• Device Sequence Number: 15963792
• Product Code: LZO
• UDI-Device Identifier: 07630030807749
• UDI-Public: 07630030807749
• Combination Product (Y/N): N
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2025
• 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): 11/21/2025

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: 09/21/2021
• Device Model Number: 01.26.45.0046
• Device Lot Number: 164410
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/04/2016
• 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 Age: 59 YR
• Patient Sex: Female
• Patient Weight: 61 KG