MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT FLAT PE HC LINER Ø36/E; HIP SHELL LINER

Model Number	02.07.0410SF
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	10/21/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came in 1 year and 7 months after the primary surgery reporting pain due to a dislocation of the head from the liner and the cause of the dislocation is unknown.The surgeon revised the competitor's head and medacta liner and the surgery was completed successfully.
Additional Manufacturer Narrative
Batch review performed on 04 november 2021: lot 1904356: (b)(4) items manufactured and released on 17-06-2019.Expiration date: 2024-05-29.No anomalies found related to the problem.To date, all items of the same lot have been already sold without similar reported event.

• Brand Name: MPACT FLAT PE HC LINER Ø36/E
• Common Device Name: HIP SHELL LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 12811746
• Report Number: 3005180920-2021-00893
• Device Sequence Number: 5484959
• Product Code: LPH
• UDI-Device Identifier: 07630030817663
• UDI-Public: 07630030817663
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K103721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• 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): 11/15/2021

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: 05/29/2024
• Device Model Number: 02.07.0410SF
• Device Catalogue Number: 01.32.3644HCT
• Device Lot Number: 1904356
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2021
• Initial Report FDA Received Date: 11/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/17/2019
• 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