MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSACEM ACETABULAR SHELL AND DOUBLE MOBILITY HC LINERS; DOUBLE MOBILITY HC LINER Ø28/DMC

Model Number	01.26.2846MHC
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/11/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 03 july 2026: mpact dm 01.26.2846mhc double mobility hc liner d 28/dmc (k241767) lot.2338169: (b)(4) items manufactured and released on 12-dec-2023.Expiration date: 22-nov-2028.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.Mpact dm 01.32.3844cf dm converter e/dmc - tin coated (k211891) lot.2309715: (b)(4) items manufactured and released on 08-nov-2023.Expiration date: 23-oct-2028.No anomalies found related to the problem.To date, all items of the same lot have been sold with one similar reported event during the period of review.Root cause:based on the information available, no definitive root cause can be established for the reported dislocation of the double mobility liner from the dm converter liner.No trauma was indicated, and the available information does not allow confirmation of a specific clinical, application-related, or device-related cause.The device history record reviews for the involved lots did not indicate any potentially related manufacturing issue, and no similar events were identified for the reviewed sold items of the same lots.
Event or Problem Description
Revision surgery due to a dislocation of the dm liner from the dm converter liner after about 1 month from primary.The surgeon revised the medacta cup, liner, dm converter and head to competitor devices.

• Brand Name: VERSACEM ACETABULAR SHELL AND DOUBLE MOBILITY HC LINERS
• Common Device Name: DOUBLE MOBILITY HC LINER Ø28/DMC
• 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: 25714727
• Report Number: 3005180920-2026-00653
• Device Sequence Number: 14737879
• Product Code: LZO
• UDI-Device Identifier: 07630542703928
• UDI-Public: 07630542703928
• Combination Product (Y/N): N
• PMA/510(K) Number: K241767
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/06/2026

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: 01.26.2846MHC
• Device Lot Number: 2338169
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2026
• Initial Report FDA Received Date: 07/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2023
• 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: 68 YR
• Patient Sex: Male