MAUDE Adverse Event Report: Medacta International SA Versafitcup CC TRIO Acetabular System; Versafitcup Metalback CC Trio Ø50 mm

Model Number	01.26.45.0050
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	08/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
At 6 months from the primary, the patient came in presenting pain and instability due to a cup that shifted position following primary surgery and the cause is unknown.The surgeon revised the medacta cup and liner to a competitor cup and liner, and revised the 36mm biolox head s to a 36mm biolox option head with option sleeve m.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 31 aug 2026 lot 2512728: 96 items manufactured and released on 22/jul/2025.Expiration date: 02/jul/2030.No anomalies found related to the problem.To date, 93 items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation performed by medical affairs director approximately six and a half months after primary cementless tha, revision surgery was performed because of pain and instability associated with reported migration of the acetabular cup.No traumatic event was reported.The available ap radiograph suggests relatively superficial acetabular preparation, with limited depth of cup engagement, which may have reduced the initial press-fit and implant-bone contact.A focal area of bone rarefaction is also visible superior to the cup and could be compatible with a pre-existing or developing cystic bone lesion; however, this cannot be confirmed from the single available image and is not mentioned in the complaint report.Considering the relatively early loss of fixation of a cementless cup, the most probable mechanism is insufficient primary stability achieved at the index procedure, with subsequent micromotion and migration before adequate osseointegration could occur.Based on the available information, there are no elements to suggest a defective or malfunctioning device.Root cause:the cup migration was most likely related to insufficient primary stability, with subsequent micromotion before adequate osseointegration.Altered bone quality may also have contributed, although this cannot be confirmed.There is no indication that any potential issue with the device may have caused or contributed to the event.

• Brand Name: Versafitcup CC TRIO Acetabular System
• Common Device Name: Versafitcup Metalback CC Trio Ø50 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: 50784461
• Report Number: 3005180920-2026-00937
• Device Sequence Number: 9415803
• Product Code: LZO
• UDI-Device Identifier: 07630030807763
• UDI-Public: 07630030807763
• 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): 09/16/2026

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: 01.26.45.0050
• Device Lot Number: 2512728
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2025
• 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 Sex: Female