MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP DOUBLE MOBILITY SHELLS; VERSAFITCUP METALBACK DM Ø58 MM

Model Number	01.26.58MB
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	04/20/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23 apr 2026 lot 2008015: (b)(4) items manufactured and released on 18-dec-2020.Expiration date: 2025-dec-08.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.Clinical evaluation performed by r&d project manager 2 years after revision hip surgery, the patient complains of pain, which is reportedly due, most likely, to psoas impingement.This seems very plausible because the dm cup protrudes significantly from the rather narrow pelvis of the patient.According to the report, the cup was well fixed, and the joint was stable, but the muscle pain required explant of the devices and implantation of an acetabular cage.No reason to suspect a faulty device at the origin of this adverse event.Root cause: 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.
Event or Problem Description
At 1 year 9 months from medacta primary surgery, the patient presented with pain.Probable iliopsoas impingement was suspected due to a slightly overhanging acetabular cup.There was no evidence of component loosening or infection.The surgeon revised the medacta cup and dm liner with a reinforcement cage (size 62) with screws, versacem 56 cup and dmh liner.

• Brand Name: VERSAFITCUP DOUBLE MOBILITY SHELLS
• Common Device Name: VERSAFITCUP METALBACK DM Ø58 MM
• 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: 25160331
• Report Number: 3005180920-2026-00402
• Device Sequence Number: 10695013
• Product Code: MEH
• UDI-Device Identifier: 07630030808203
• UDI-Public: 07630030808203
• Combination Product (Y/N): N
• PMA/510(K) Number: K083116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 05/13/2026

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 Expiration Date: 12/08/2025
• Device Model Number: 01.26.58MB
• Device Lot Number: 2008015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2020
• 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: 78 YR
• Patient Sex: Male
• Patient Weight: 95 KG