MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA DOUBLE MOBILITY LINER; DOUBLE MOBILITY LINER Ø28/DML

Model Number	01.26.2860M
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Joint Laxity (4526); Implant Pain (4561)
Date of Event	03/05/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 09 mar 2026.Liner: versafitcup dm 01.26.2860m double mobility liner d 28/dml lot 090903: (b)(4) items manufactured and released on 12-jun-2009.Expiration date: 2014-apr-30.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 clinical affairs director 17 years after primary cementless tha with a dm cup and a standard pe liner, wear of the mobile insert requires revision.Wear of standard pe after more than 15 years is to be expected, therefore we do not consider this event an anomaly, and there is no reason to suspect a faulty device.Root cause:standard pe wear is a known possible complication after hip replacement surgery and the causes are often related to several factors.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
At16 years 6 months from the primary, the patient came in presenting pain and instability due to a worn liner.The surgeon revised the d 28 head to a 28mm biolox option head with a medium sleeve, and revised the 60mm x 28 versafit liner for a d 28 double mobility liner.The surgery was completed successfully.

• Brand Name: DOUBLE MOBILITY LINER
• Common Device Name: DOUBLE MOBILITY LINER Ø28/DML
• 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: 24741264
• Report Number: 3005180920-2026-00256
• Device Sequence Number: 8772499
• Product Code: MEH
• UDI-Device Identifier: 07630030807466
• UDI-Public: 07630030807466
• Combination Product (Y/N): N
• PMA/510(K) Number: K083116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• 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): 03/31/2026

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: 04/30/2014
• Device Model Number: 01.26.2860M
• Device Lot Number: 090903
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2009
• 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