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

Catalog Number 01.32.3652HCT

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Joint Dislocation (2374)

Event Date 08/07/2023

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 322616494
• Report Number: 3005180920-2023-00664
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07630030812156
• UDI-Public: 07630030812156
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103721
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/04/2023
• Device Catalogue Number: 01.32.3652HCT
• Device Lot Number: 187910
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/07/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/10/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male