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

Catalog Number	01.32.3652HCT
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	08/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 29 august 2023.Lot 187910: (b)(4) items manufactured and released on 10-oct-2018.Expiration date: 2023-oct-04.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.Additional device involved.Batch review performed on 29 august 2023.Cocr 01.25.030 cocr ball head 12/14 ø 36 size s -3.5 (k080885) lot 1900780: (b)(4) items manufactured and released on 29-may-2019.Expiration date: 2024-may-19.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) 2019.On (b)(6) 2022, the patient came in reporting pain due to a dislocation of the head from the liner.The surgeon revised the medacta stem and head with a competitor's components but retained the medacta mpact flat liner.The surgery was completed successfully.Presently, on (b)(6) 2023, the patient came in 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 head with a competitor's product and revised the medacta liner with a medacta liner.The surgery was completed successfully.A posterior approach was used in the primary surgery.

• Brand Name: MPACT FLAT PE HC LINER Ø36/G
• Common Device Name: SHELL INSERT
• 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: 17682002
• Report Number: 3005180920-2023-00664
• Device Sequence Number: 2609017
• Product Code: LPH
• UDI-Device Identifier: 07630030812156
• UDI-Public: 07630030812156
• 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: 2019
• Device Explanted Year: 2023
• 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): 09/05/2023

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: 10/04/2023
• Device Catalogue Number: 01.32.3652HCT
• Device Lot Number: 187910
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2023
• Initial Report FDA Received Date: 09/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/10/2018
• 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