MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT OFFSET 4MM PE HC LINER 32/C; HIP SHELL LINER

Model Number	01.32.3239HC4
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	12/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 18 december 2020: lot 2002179: 15 items manufactured and released on 2-jun-2020.Expiration date: 2025-05-13.No anomalies found related to the problem.To date, 2 items of the same lot have been already sold without any similar reported event.
Event or Problem Description
The patient came in after 1 month from the previous revision surgergery reporting pain due to a dislocation of the head (competitor) from the liner (medacta).The cause of the dislocation is unknown.The surgeon revised the competitor head and the medacta liner.The surgery was completed successfully.Previous revision surgery reason was stem mobilization (the stem and head were revised).

• Brand Name: MPACT OFFSET 4MM PE HC LINER 32/C
• Common Device Name: HIP SHELL LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 11106982
• Report Number: 3005180920-2021-00005
• Device Sequence Number: 3596023
• Product Code: LPH
• UDI-Device Identifier: 07630040730754
• UDI-Public: 07630040730754
• 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: 2020
• Device Explanted Year: 2020
• 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): 01/04/2021

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: 05/13/2025
• Device Model Number: 01.32.3239HC4
• Device Catalogue Number: 01.32.3239HC4
• Device Lot Number: 2002179
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2020
• Initial Report FDA Received Date: 01/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention