MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA DOUBLE MOBILITY LINER; HC PE LINER 28 / DMD

Model Number	01.26.2848MHC
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	04/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
At about 12 years from primary, the patient came in reporting pain and the cause was unknown.Upon revising, the surgeon observed an eccentrically worn dm construct.The surgeon revised the head and liner.The surgery was complete successfully.
Additional Manufacturer Narrative
Clinical evaluation: a revision surgery was performed 12 years after the primary total hip arthroplasty due to pain.However, the available imaging does not clearly reveal a specific cause, as no obvious defects are visible.It is reported that an eccentrically worn dual dm liner was observed during the revision, but we lack visual evidence to confirm this finding.Therefore, no definitive conclusions can be drawn regarding the root cause of the failure.Preliminary investigation: from the images, it is notable that the polyethylene dual mobility liner was explanted; the external surface appeared yellowed, but as no particular signs are visible, it was not possible to determine the root cause of the event.Batch review performed on 22 apr 2025.Lot 124627: (b)(4) items manufactured and released on 16-01-2013.Expiration date: 2017-12-31.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Additional device involved and revised: batch review performed on 22 apr 2025.Ball heads: mectacer 01.29.201 mectacer head biolox delta dia.28 12/14-s (k112115) lot.124959: (b)(4) items manufactured and released on 14-01-2013.Expiration date: 2017-12-31.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.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: HC PE LINER 28 / DMD
• 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: 22058501
• Report Number: 3005180920-2025-00442
• Device Sequence Number: 8478144
• Product Code: MEH
• UDI-Device Identifier: 07630030807244
• UDI-Public: 07630030807244
• 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: 2013
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/21/2025

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: 12/31/2017
• Device Model Number: 01.26.2848MHC
• Device Lot Number: 124627
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2025
• Initial Report FDA Received Date: 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/16/2013
• 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: Female