MAUDE Adverse Event Report: Medacta International SA Versafitcup CC TRIO Acetabular System; Versafitcup Metalback CC Trio Ø46 mm

Model Number	01.26.45.0046
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	08/25/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 07 august 2026 cup: versafitcup cc trio 01.26.45.0046 versafitcup metalback cc trio d 46 mm (k103352) lot.2528368: (b)(4) items manufactured and released on 18-feb-2026.Expiration date: 2031-01-25.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 a revision surgery was performed 24 days after a primary hybrid tha performed for a femoral fracture following a fall.The acetabular component was cementless and screw-assisted.According to the report, the postoperative radiograph already showed marked medial migration of the cup and screws through the acetabulum.The available image is consistent with severe loss of medial acetabular support and intrapelvic protrusion of the acetabular construct.The bone appears radiographically rarefied, suggesting reduced bone quality, which, together with the patient`s advanced age and mechanical loading, may have contributed to acetabular bone failure.Given that the finding was identified immediately after the index procedure, insufficient primary acetabular support, an occult acetabular fracture or medial wall weakening during preparation are plausible contributing mechanisms.At revision, the cup was reportedly easily removed without evidence of fixation, and pelvic reconstruction was required.No explanted device was available for investigation.Based on the available information, there are no elements to suggest a defective or malfunctioning device.Analysis performed by r&d manager: from the image available the explanted cup and screws are visible and covered with patient blood.The screws are still inside the holes of the cup.The image does not identify any apparent abnormalities, deformation, breakage, or other findings suggestive of a device defect or malfunction.At revision, the cup was reportedly easily removed without evidence of fixation, and pelvic reconstruction was required.No explanted device was available for investigation.Based on the available information, there are no elements to suggest a defective or malfunctioning device.Root cause:based on the information available, no definitive root cause can be established, while the case appears to be influenced by case-specific clinical and/or application-related factors affecting primary acetabular support.There is no indication that a device defect or potentially related manufacturing issue caused or contributed to the event.
Event or Problem Description
At about 1 month after the primary thr (performed following a femoral fracture due to a fall), revision surgery was performed due to penetration of the acetabular cup and screws through the acetabulum observed on postoperative x-ray.The cup and screws were easily removed using forceps, without a screwdriver.Pelvic reconstruction was performed, followed by implantation of a competitor`s cemented dual-mobility cup and exchange of the medacta femoral head.Surgery was completed successfully.

• Brand Name: Versafitcup CC TRIO Acetabular System
• Common Device Name: Versafitcup Metalback CC Trio Ø46 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: 50692321
• Report Number: 3005180920-2026-00917
• Device Sequence Number: 9595744
• Product Code: LZO
• UDI-Device Identifier: 07630030807749
• UDI-Public: 07630030807749
• 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
• Type of Report: Initial
• Report Date (Section B): 09/09/2026

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: 01.26.45.0046
• Device Lot Number: 2528368
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2026
• 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: 88 YR
• Patient Sex: Female
• Patient Weight: 173 LB
• Patient Race: White