MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP CC TRIO ACETABULAR SYSTEM; VERSAFITCUP CC TRIO VERSAFITCUP METALBACK CC TRIO Ø52 MM

Model Number	01.26.45.0052
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery for an iatrogenic acetabulum bone fracture about 11 days after the primary.According to the surgeon, post-op x-rays suggest possible overreaming.The fracture is also attributed to the patient's poor bone quality (a woman of 87 years old).The patient had poor bone quality.All components were revised successfully.
Additional Manufacturer Narrative
Clinical evaluation performed by medacta medical affairs manager: a revision surgery was required a few days after the primary tha due to a periprosthetic acetabular fracture.The fracture was reported as iatrogenic, most likely resulting from over-reaming or weakening of the acetabulum during impaction in a patient with poor bone quality.No traumatic event was documented.The only available imaging (a single ct scan slice) confirms the presence of the acetabular fracture but does not allow for any further clinically relevant assessment.Based on the information available, there is no indication of a device defect or malfunction.Batch review performed on 28 july 2025: lot 2504484: (b)(4) items manufactured and released on 17 april 2025.Expiration date: 30-march-2030.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.Based on the information available no definitive root cause can be established, while 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.The fracture likely resulted from over-reaming or excessive force during impaction, which may have compromised the integrity of the acetabulum, particularly in a patient with poor bone quality.

• Brand Name: VERSAFITCUP CC TRIO ACETABULAR SYSTEM
• Common Device Name: VERSAFITCUP CC TRIO VERSAFITCUP METALBACK CC TRIO Ø52 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: 22714428
• Report Number: 3005180920-2025-00757
• Device Sequence Number: 9393533
• Product Code: LZO
• UDI-Device Identifier: 07630030807770
• UDI-Public: 07630030807770
• 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: 2025
• 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): 08/05/2025

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 Model Number: 01.26.45.0052
• Device Lot Number: 2504484
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/17/2025
• 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: 80 YR
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Race: White