MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP CC TRIO ACETABULAR SYSTEM; FLAT PE HC LINER Ø32/C

Model Number	01.26.3239HCT
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 2 years 7 months after the primary, the patient came in presenting pain as the result of a dislocation of the head and liner and the cause is unknown.No trauma is reported.The surgeon revised the head and liner.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 11 february 2026 ball heads: mectacer 01.29.205 mectacer head biolox delta dia.32 12/14-m (k112115) lot: 2237479: (b)(4) items manufactured and released on 13-feb-2022.Expiration date: 2027-11-27.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.Liner: versafitcup cc trio 01.26.3239hct flat pe hc liner ø32/c (k120531) lot: 2239498: (b)(4) items manufactured and released on 14-nov-2022.Expiration date: 2027-11-01.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: 2.5 years after primary cementless tha on an elderly lady, dislocation occurs.The surgeon replaces head and insert, presumably because the bone-contacting components were well fixed and well positioned.He used a longer head to give additional tension and stability to the joint.This adverse event was not originated by a faulty of malfunctioning device.Root cause: dislocation is a possible literature-described adverse event after primary joint arthroplasties and causes are often unknown.There is no indication that any potential issue with the device may have caused or contributed to the event.No previous case has been addressed to a device design or manufacturing related root cause.

• Brand Name: VERSAFITCUP CC TRIO ACETABULAR SYSTEM
• Common Device Name: FLAT PE HC LINER Ø32/C
• 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: 24429829
• Report Number: 3005180920-2026-00146
• Device Sequence Number: 10304346
• Product Code: LZO
• UDI-Device Identifier: 07630030807541
• UDI-Public: 07630030807541
• Combination Product (Y/N): N
• PMA/510(K) Number: K120531
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 02/24/2026

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: 01.26.3239HCT
• Device Lot Number: 2239498
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2022
• 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: 81 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Race: White