MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA DOUBLE MOBILITY LINER; HIP DOUBLE MOBILITY HC LINER

Model Number	01.26.2848MHC
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Pain (1994); Joint Impingement (4834)
Date of Event	08/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23-aug-2024.Lot 153654: (b)(4) items manufactured and released on 01-oct-2015.Expiration date: 2020-08-31.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event during the period of review.
Event or Problem Description
The patient came in reporting pain due to impingement with the dual mobility liner and iliopsoas, 8 year and 8 months after the primary.The surgeon revised the head and liner.The surgery was completed successfully.The surgeon replaced the head with a +7 option sleeve and new dual mobility liner.He witnessed a significant amount of scar tissue around the acetabulum.
Additional Manufacturer Narrative
During a random mdr check conducted on october 1, 2024, an error was noticed.A follow-up is being initiated to correct it.B3 event date corrected.D1 brand name corrected.D4 model number inserted in the correct field.G4 (k) number inserted in the correct field.

• Brand Name: DOUBLE MOBILITY LINER
• Common Device Name: HIP DOUBLE MOBILITY HC LINER
• 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: 20143208
• Report Number: 3005180920-2024-00706
• Device Sequence Number: 7482459
• 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: 2015
• Device Explanted Year: 2024
• 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): 10/11/2024

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: 08/31/2020
• Device Model Number: 01.26.2848MHC
• Device Catalogue Number: 01.26.2848MHC
• Device Lot Number: 153654
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2015
• 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: 63 YR
• Patient Sex: Female