MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP CC TRIO ACETABULAR SYSTEM; FLAT PE LINER Ø 32 / E

Model Number	01.26.3244STT
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 24-02-2025: lot 171710: (b)(4) items manufactured and released on 12-06-2017.Expiration date: 2022-05-25.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation performed by medical affairs department: a revision surgery was performed approximately 7.5 years after the implantation of a tha.The reported cause of the revision is wear of the standard pe liner.The available fluoroscopic images show that the femoral head has lost its center of rotation within the liner, appearing decentered, which is an indirect sign of pe wear.But, at the same time we do not see any evident signs of osteolysis, that is often associated.Additionally, bone rarefaction is visible in the medio-caudal region of the acetabulum, which may indicate migration of the cup, not necessarily related to the pe wear.Wear of the standard pe liner over an extended period of time is well-documented in the literature as a common and expected phenomenon.The migration of the cup indicates loosening, which is another mechanism of failure reported in the literature, though its causes are often unknown.Therefore, we do not consider this to be indicative of a faulty product.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
At about 7 years and 5 months from primary the surgeon performed a revision due to wear of pe liner.Displacement of head center of rotation was reported while cup fixation was good.Head, liner and cup were all revised and surgery was completed successfully.

• Brand Name: VERSAFITCUP CC TRIO ACETABULAR SYSTEM
• Common Device Name: FLAT PE LINER Ø 32 / E
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 21594646
• Report Number: 3005180920-2025-00172
• Device Sequence Number: 15688139
• Product Code: LZO
• UDI-Device Identifier: 07630030807589
• UDI-Public: 07630030807589
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K103352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/13/2025

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 Expiration Date: 05/25/2022
• Device Model Number: 01.26.3244STT
• Device Lot Number: 171710
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2025
• Initial Report FDA Received Date: 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/12/2017
• 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 Weight: 80 KG