MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP CC TRIO ACETABULAR SYSTEM; VERSAFITCUP METALBACK CC TRIO Ø58 MM

Model Number	01.26.45.0058
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Aseptic loosening (4883)
Date of Event	12/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
At about2 years and 1 monthfrom the primary, the patientcame in reporting pain due toloosening of the acetabular shell.There was no loosening of the femoral component and no infection.The surgeon revised cup, head and liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 2 december 2025.Lot 2303353: (b)(4) items manufactured and released on 24-may-2023.Expiration date: 07-may-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.Clinical evaluation 2 years after primary cementless tha, the cup is found mobilized and needs revision.We were given only the pre-revision xray, that shows a cup significantly lateralized, with marked protrusion from the superior aspect of the acetabulum.We do not have the post-primary radiograph, so we cannot tell with certainty if this position is the result of a migration process or if this was the original position.It is clear from the image that at pre-revision the bone contact of the cup is limited and poor, and if this was the postoperative condition, the cause for mobilization should be sought in the cup position.Root cause:aseptic loosening is a possible literature-described adverse event after primary joint arthroplasties and causes are often unknown.There is no indication that any potential issue with the device may have caused or contributed to the event.No previous case has been addressed to a device design or manufacturing related root cause.

• Brand Name: VERSAFITCUP CC TRIO ACETABULAR SYSTEM
• Common Device Name: VERSAFITCUP METALBACK CC TRIO Ø58 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: 23836925
• Report Number: 3005180920-2025-01239
• Device Sequence Number: 20103968
• Product Code: LZO
• UDI-Device Identifier: 07630030807800
• UDI-Public: 07630030807800
• Combination Product (Y/N): N
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 12/18/2025

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: 01.26.45.0058
• Device Lot Number: 2303353
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2023
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 95 KG