MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP CC TRIO ACETABULAR SYSTEM; VERSAFITCUP CC TRIO VERSAFITCUP METALBACK CC TRIO Ø56 MM

Model Number	01.26.45.0056
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	05/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 1 year and 2 months from primary the patient undergone revision surgery due to infection that has grown in the implant area.Area of interest showed pus and high cellular activity.Surgeon suspects that an infection has migrated to the implant area from somewhere else.All implants were revised and antibiotic spacer was implanted; surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 12-may-2025 lot 2312670: (b)(4) items manufactured and released on 11-10-2023.Expiration date: 2028-09-24.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.Additional devices involved.Batch review performed on 12-may-2025.Mectacer 01.29.209 mectacer head biolox delta dia.36 12/14-m (k112115) lot 2346008: (b)(4) items manufactured and released on 13-12-2023.Expiration date: 2028-11-27.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.Quadra-h 01.12.035 cementless, ha coated lat stem size 5 (k082792) lot 174069a: (b)(4) items manufactured and released on 26-01-2023.Expiration date: 2028-01-10.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.(lot 174069 (b)(4) items manufactured and released on 03-11-2017.All items have been sold with no similar reported event during the period of review.) liner not marketed in the usa: mectacer 01.29.414 mectacer insert biolox delta xlw18 dia.36/48g lot 2347196: (b)(4) items manufactured and released on 09-01-2024.Expiration date: 2028-12-10.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.Preliminary investigation performed by r&d department: acetabular implant: from the images, it is notable that the liner is still inside the shell; both the devices are shown just explanted, so covered with blood and some soft tissue (in the external surface of shell); no particular signs are visible, so it was not possible to determine the root cause of the event.Femural implant:looking at the images attached to the complaint it is visible the explanted stem covered by patient blood.Some white spots are visible on the stem body part but it is not clear if they are bone or ha residuals.Some signs and scratches are visible on the neck part probably due to revision surgery.It is not possible to define the root cause of reported complaint.Infection is a known possible complication of any surgery.Although no root cause can be established, there is no indication that any issue with the device may have caused or contributed to the event, and the document review does not indicate any potential manufacturing related cause.

• Brand Name: VERSAFITCUP CC TRIO ACETABULAR SYSTEM
• Common Device Name: VERSAFITCUP CC TRIO VERSAFITCUP METALBACK CC TRIO Ø56 MM
• 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: 22084241
• Report Number: 3005180920-2025-00485
• Device Sequence Number: 12729285
• Product Code: LZO
• UDI-Device Identifier: 07630030807794
• UDI-Public: 07630030807794
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 05/26/2025

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 Model Number: 01.26.45.0056
• Device Lot Number: 2312670
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 05/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/11/2023
• 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 Age: 45 YR
• Patient Sex: Male
• Patient Weight: 120 KG
• Patient Race: White