MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSACEM ACETABULAR SHELL AND DOUBLE MOBILITY HC LINERS; VERSACEM METALBACK Ø56 MM

Model Number	01.27.56CMB
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	05/19/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 05 june 2026: lot 2421995: (b)(4) items manufactured and released on 07-feb-2025.Expiration date: 26-dec-2029.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 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
The patient initially underwent primary surgery with competitor products.On (b)(6) 2025, the patient underwent revision surgery due to infection; during this procedure, the competitor shell, liner, and head were revised and medacta implants were implanted.On (b)(6) 2026, the patient presented with pain related to loosening of the versacem metalback cup from the acetabulum.No trauma or fall was reported, and the cause of the loosening remains unknown.The surgeon revised the versacem metalback cup to an mpact 3d metal multi-hole cup and replaced the double mobility hc liner d 28/dmh with a double mobility hc liner d 28/dme together with a dm converter.The revision surgery was completed successfully.

• Brand Name: VERSACEM ACETABULAR SHELL AND DOUBLE MOBILITY HC LINERS
• Common Device Name: VERSACEM METALBACK Ø56 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: 25442532
• Report Number: 3005180920-2026-00545
• Device Sequence Number: 5726149
• Product Code: LZO
• UDI-Device Identifier: 07630030808449
• UDI-Public: 07630030808449
• Combination Product (Y/N): N
• PMA/510(K) Number: K241767
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 06/09/2026

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: 01.27.56CMB
• Device Lot Number: 2421995
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2025
• 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 Sex: Male