MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: MPACT FACE-CHANGING 10° PE HC LINER Ø36/E; HIP LINER

Catalog Number	01.32.3644HC10A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	03/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 15 march 2024: lot 2009675: (b)(4) items manufactured and released on 01-dec-2020.Expiration date: 2025-11-17.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with another similar reported event during the period of review.Additional implant involved, batch review performed on (b)(6) 2024: ball heads: mectacer 01.29.232h head biolox option ø 36 (k131518) lot.2303258: (b)(4) items manufactured and released on 16-feb-2023.Expiration date: 2028-02-13.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.
Event or Problem Description
The patient had a primary hip surgery on (b)(6) 2018.On (b)(6) 2023, the patient came in reporting pain due to a dislocation of the head from the liner that was caused from falling.The surgeon revised the head and liner.The surgery was completed successfully.Presently, on (b)(6) 2024, the patient came in reporting pain due to a dislocation of the head from the liner and the cause is unknown.The surgeon revised the cup, liner, screws and head.The surgery was completed successfully.

• Brand Name: LINER: MPACT FACE-CHANGING 10° PE HC LINER Ø36/E
• Common Device Name: HIP 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: 19039614
• Report Number: 3005180920-2024-00201
• Device Sequence Number: 7242420
• Product Code: LPH
• UDI-Device Identifier: 07630040731034
• UDI-Public: 07630040731034
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K183582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/04/2024

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: 11/17/2025
• Device Catalogue Number: 01.32.3644HC10A
• Device Lot Number: 2009675
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2024
• Initial Report FDA Received Date: 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2020
• 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: Female