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

Model Number	01.26.45.0052
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	04/28/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 05-may-2026 lot 2525687: (b)(4) items manufactured and released on 28-jan-2026.Expiration date: 2030-dec-02.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 device history record review does not indicate any potential manufacturing-related issue.
Event or Problem Description
Revision surgery due to acetabular cup malpositioning after about 1 month from primary.The acetabular components and femoral head were explanted and replaced with cemented components and a dual mobility bearing.

• Brand Name: VERSAFITCUP CC TRIO ACETABULAR SYSTEM
• Common Device Name: VERSAFITCUP METALBACK CC TRIO Ø52 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: 25185359
• Report Number: 3005180920-2026-00443
• Device Sequence Number: 10692590
• Product Code: LZO
• UDI-Device Identifier: 07630030807770
• UDI-Public: 07630030807770
• Combination Product (Y/N): N
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 05/15/2026

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: 01.26.45.0052
• Device Lot Number: 2525687
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2026
• 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: 84 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White