MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP CC TRIO ACETABULAR SYSTEM; VERSAFITCUP METALBACK CC TRIO Ø48 MM

Model Number	01.26.45.0048
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	06/15/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 june 2026 cup: versafitcup cc trio 01.26.45.0048 versafitcup metalback cc trio d 48 mm (k103352) lot 2523812: (b)(4) items manufactured and released on 24-dec-2025.Expiration date: 23-nov-2030.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with one similar reported event during the period of review.Clinical evaluation a technical error occurred during primary cementless tha, that led to a wrong position of the acetabular cup.The patient was reoperated after few weeks and an acatbular cage with a cemented-in pe cup was placed in the acetabulum.The femoral component was correctly implanted and well fixed and it was left in place.No malfunction or defect of any implanted device.Root cause: based on the available clinical information, the revision was required due to incorrect positioning of the acetabular cup during the primary surgery, which subsequently led to cup loosening.The event is therefore considered related to an application-specific technical error during implantation.There is no indication that any malfunction or defect of the implanted devices caused or contributed to the event.
Event or Problem Description
Primary surgery was performed on (b)(6) 2026.On (b)(6) 2026, revision surgery was performed on the left side.According to the surgeon, the revision was required due to incorrect positioning of the acetabular implant during the primary surgery, with subsequent implant loosening.No loosening of the femoral stem and no infection were reported.All components were explanted, except for the minimax stem.Reimplantation was performed using a reinforcement cage, an apricot 44, and a crco ball head 32 m.

• Brand Name: VERSAFITCUP CC TRIO ACETABULAR SYSTEM
• Common Device Name: VERSAFITCUP METALBACK CC TRIO Ø48 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: 25778111
• Report Number: 3005180920-2026-00633
• Device Sequence Number: 10686873
• Product Code: LZO
• UDI-Device Identifier: 07630030807756
• UDI-Public: 07630030807756
• 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): 07/10/2026

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: 01.26.45.0048
• Device Lot Number: 2523812
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2026
• Initial Report FDA Received Date: 07/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/24/2025
• 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: 73 YR
• Patient Sex: Female
• Patient Weight: 60 KG