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

Model Number	01.26.3244HCT
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 11-apr-2025.(b)(4) items manufactured and released on 06-may-2015.Expiration date: 31-mar-2020.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported event during the period of review.Clincal evaluation performed by clinical affaits department.A revision surgery was performed approximately 10 years after the primary implantation of a total hip arthroplasty.The patient presented with complaints of pain and underwent a clinical follow-up.The available x-ray images reveal a region of osteolysis in the acetabular area, located above the cup.This finding is partially obscured by an informational artifact from the x-ray itself.Additionally, a separate area of osteolysis is noted in the trochanteric region.However, since the revision involved only the acetabular component, it can be inferred that the femoral stem remained stable.The underlying cause of this finding is difficult to determine based on the available information.No definitive cause for this adverse event can be established.Visual inspection performed by r&d department.From the received pieces, the liner appeared yellowed: no particular or evident signs were noticed, except for the presence of a hole created for removal.The ceramic ball head presented some signs on its surface.It is not possible to determine the root cause of the event.Additional involved devices.Versafitcup cc trio 01.26.45.1152 acetabular shell cc trio no-hole ø 52 (k103352) lot.150076 batch review performed on 11-apr-2025.(b)(4) items manufactured and released on 11-may-2015.Expiration date: 31-mar-2020.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.38.49.7175.675.00 biolox delta ceramic ball head 12/14 ø 28 size m 0 not marketed in us.
Event or Problem Description
Revision surgery performed due to pain at about 10 years from the primary surgery.Liner and ball head revised successfully.

• Brand Name: VERSAFITCUP CC TRIO ACETABULAR SYSTEM
• Common Device Name: FLAT PE HC 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: 21932981
• Report Number: 3005180920-2025-00357
• Device Sequence Number: 21031669
• Product Code: LZO
• UDI-Device Identifier: 07630030807572
• UDI-Public: 07630030807572
• 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: 2015
• 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): 04/29/2025

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: 03/31/2020
• Device Model Number: 01.26.3244HCT
• Device Lot Number: 150102
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2015
• 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: Male