MAUDE Adverse Event Report: Medacta International SA Versafitcup Double Mobility Shells; Acetabular shell Ø 52

Model Number	01.26.52MB
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision at 5 days from primary surgery for bone fracture.The reason of fracture is unknown.The shell was found in a different position from the primary, likely as a secondary effect of the fracture.Shell, liner, and head revised successfully.
Additional Manufacturer Narrative
Batch review performed on 24 july 2026: lot 2516641: (b)(4) items manufactured and released on 03-dec-2025.Expiration date: 23-nov-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.Root cause:based on the available information, the reported bone fracture is considered the most likely cause of the change in shell position and the subsequent early revision.However, in the absence of further clinical or radiographic information, the relationship between the fracture and shell displacement cannot be conclusively established.The batch review did not identify any potentially related manufacturing issue.

• Brand Name: Versafitcup Double Mobility Shells
• Common Device Name: Acetabular shell Ø 52
• 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: 50114135
• Report Number: 3005180920-2026-00810
• Device Sequence Number: 20159888
• Product Code: MEH
• UDI-Device Identifier: 07630030808098
• UDI-Public: 07630030808098
• Combination Product (Y/N): N
• PMA/510(K) Number: K083116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 08/03/2026

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: 01.26.52MB
• Device Lot Number: 2516641
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2026
• Initial Report FDA Received Date: 08/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2025
• 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: 72 YR
• Patient Sex: Female
• Patient Weight: 209 LB