MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP CC TRIO ACETABULAR SYSTEM; ACETABULAR SHELL CC TRIO Ø52

Model Number	01.26.45.0052
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	10/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery performed approximately 13 years and 5 months after the primary procedure due to cup loosening secondary to granuloma-induced bone resorption.Cup, liner and head successfully revised.
Additional Manufacturer Narrative
Batch review performed on 10 november 2025: lot 120056: (b)(4) items manufactured and released on 09-march-2012.Expiration date: 2017-02-28.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported events during the period of review.Clinical evaluation: 13.5 years after primary cementless tha with ceramic-on-ceramic bearing, a granuloma develops and the acetabular component slips out of place.The early postoperative radiographs were not supplied, the first image available in chronological order already shows a significantly damaged acetabulum and bone loss.We cannot infer what the cause of the damage could be; there are no reports of intraoperative findings (such as metallosis) that could indicate a conflict between neck of the stem and acetabular insert.The foreign body reaction is very rare in a ceramic-on-ceramic coupling, as there is virtually no wear and the wear particles are inert.With no additional information, a reliable root cause determination is not feasible.Visual inspection: the ceramic liner was still inside the versafitcup shell, which was apparently without particular signs or damages related to implant failure.Also, some presence of fibrotic tissue was present in macrostructures and polar area.From the received information and pieces there are no reasons to suspect an implant failure, being the root cause a granuloma that caused a bone resorption, bringing to implant loosening.Conclusion: 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 device history record review does not indicate any potential manufacturing related issue.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 device history record review does not indicate any potential manufacturing related issue.

• Brand Name: VERSAFITCUP CC TRIO ACETABULAR SYSTEM
• Common Device Name: ACETABULAR SHELL CC TRIO Ø52
• 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: 23591899
• Report Number: 3005180920-2025-01118
• Device Sequence Number: 15997142
• Product Code: LZO
• UDI-Device Identifier: 07630030807770
• UDI-Public: 07630030807770
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2025
• 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): 11/19/2025

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: 02/28/2017
• Device Model Number: 01.26.45.0052
• Device Lot Number: 120056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/09/2012
• 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: 80 YR
• Patient Sex: Male