MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA DOUBLE MOBILITY LINER; VERSAFITCUP DOUBLE MOBILITY HC LINER Ø 54/28

Model Number	01.26.2854MHC
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Joint Dislocation (2374)
Date of Event	05/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 22 may 2025.(b)(4) items manufactured and released on 20-oct-2020.Expiration date: 2025-10-05.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.Additional devices involved: cup: versafitcup 01.26.54mb acetabular shell ø 54 (k083116) lot.163912.Batch review performed on 23 may 2025: (b)(4) items manufactured and released on 11-oct-2016.Expiration date: 2021-09-28.No anomalies found related to the problem.To date, all the items of the same lot have been sold with no similar reported event during the period of review.
Event or Problem Description
The patient had a primary hip surgery on (b)(6) 2017.On (b)(6) 2017, the patient came in reporting of pain.The surgeon revised the stem, head and liner.The surgeon used another company's stem with a medacta head and liner.The surgery was completed successfully.On (b)(6) 2024, the patient came in reporting pain due to a broken stem.The surgeon revised the competitor stem and revised the medacta head and liner.The surgery was completed successfully.On (b)(6) 2025, the patient came in reporting pain due to the head dislocating from the versafitcup dm shell.The surgeon revised the head and liner.The surgery was completed successfully.
Additional Manufacturer Narrative
D9.Corrected because on the 10th of july we have received the information that the device is not available for evaluation.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.

• Brand Name: DOUBLE MOBILITY LINER
• Common Device Name: VERSAFITCUP DOUBLE MOBILITY HC LINER Ø 54/28
• 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: 22201170
• Report Number: 3005180920-2025-00531
• Device Sequence Number: 17813032
• Product Code: MEH
• UDI-Device Identifier: 07630030807381
• UDI-Public: 07630030807381
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K092265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2025

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 Expiration Date: 10/05/2025
• Device Model Number: 01.26.2854MHC
• Device Lot Number: 2007573
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2020
• 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 Sex: Unknown