MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP CC TRIO ACETABULAR SYSTEM; VERSAFITCUP METALBACK CC TRIO NO-HOLE Ø50 MM

Model Number	01.26.45.1150
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	12/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 17 december 2025: lot 2436356: 64 items manufactured and released on 17-mar-2025.Expiration date: 2030-feb-24.No anomalies found related to the problem.To date, 61 items of the same lot have been sold with no similar reported event during the period of review.Root cause:aseptic loosening 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.
Event or Problem Description
Revision surgery due to shell loosening at 6 months post op.
Additional Manufacturer Narrative
Piece returned on (b)(6) 2026.Visual inspection performed by medacta hip r&d project manager: from the received piece, no particular signs of device failure were noticed: ha coating is partially absent, indicating metabolic activity, while some fibrotic tissue was present in the external surface and in the macrostructures of the shell, potentially indicating a proper osseointegration and fixation.In the ceramic liner, a sign on the internal rim was noticed, but we don't have the evidence if this is due to impingement with the stem or if it occurred during the revision surgery.From the received information, it is not possible to determine the root cause of the event, but there are no reasons to suspect a failure of the device.Conclusion: aseptic loosening 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: VERSAFITCUP METALBACK CC TRIO NO-HOLE Ø50 MM
• 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: 23876947
• Report Number: 3005180920-2025-01291
• Device Sequence Number: 15858663
• Product Code: LZO
• UDI-Device Identifier: 07630030807886
• UDI-Public: 07630030807886
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K122911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2026

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: 01.26.45.1150
• Device Lot Number: 2436356
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/17/2025
• 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 Age: 67 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White