MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT ACETABULAR SHELL Ø52 TWO-HOLES; HIP ACETABULAR SHELL

Catalog Number 01.32.152DH

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/19/2022

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 22 august 2023: lot 2004896: 75 items manufactured and released on 24-sep-2020.Expiration date: 2025-09-15.No anomalies found related to the problem.To date, all items of the same lot have been sold without any similar reported event during the period of review.Clinical evaluation: revision about 2 months and half after the primary tha, due to malpositioning of the cup.No reason to suspect defective or malfunctioning implant.

Event Description

At about 2 months and half after the primary, revision surgery performed due to hip dislocation caused by malpositioning of the cup.The surgeon revised successfully cup components and head and implanted a competitor's cup and a constrained liner due to patient's anatomy presumably increasing the risk of dislocation as well.

• Brand Name: MPACT ACETABULAR SHELL Ø52 TWO-HOLES
• Type of Device: HIP ACETABULAR SHELL
• 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: 17773089
• MDR Text Key: 323720509
• Report Number: 3005180920-2023-00661
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K132879
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 01.32.152DH
• Device Lot Number: 2004896
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/24/2020
• 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 Age: 61 YR
• Patient Sex: Female