MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA DOUBLE MOBILITY LINER; DOUBLE MOBILITY LINER Ø 52/28

Model Number	01.26.2852M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unequal Limb Length (4534)
Date of Event	02/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient had significant leg discrepancy and the cause is unknown.The surgeon revised head and liner at about 16 years after primary and checked the stem and cup to ensure they were stable and had not become loose.It is unclear what may have contributed.The surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 10 february 2026: lot 093073: (b)(4) items manufactured and released on 15-feb-2010.Expiration date: 2014-dec-31.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.Device supplier analysis: the component properties and the microstructure as obtained from the quality documents fulfil the requirements as specified at the time of production.There is no indication of any preexisting material defect.Due to the fact that the femoral head at issue was not provided, ceramtec could not carry out any further investigations.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 investigation does not indicate any potential manufacturing related issue.

• Brand Name: DOUBLE MOBILITY LINER
• Common Device Name: DOUBLE MOBILITY LINER Ø 52/28
• 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: 24454888
• Report Number: 3005180920-2026-00134
• Device Sequence Number: 21324226
• Product Code: MEH
• UDI-Device Identifier: 07630030807336
• UDI-Public: 07630030807336
• Combination Product (Y/N): N
• PMA/510(K) Number: K083116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• 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): 02/26/2026

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: 12/31/2014
• Device Model Number: 01.26.2852M
• Device Lot Number: 093073
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2010
• 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