MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT HX PE ACETABULAR LINER; PE ACETABULAR INSERT Ø 36

Catalog Number 01.32.3644HCT

Device Problem Contamination (1120)

Patient Problem Unspecified Infection (1930)

Event Date 07/07/2017

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 31 july 2017.(b)(4).

Event Description

The patient came in due to signs of infection.The surgeon washed out the hip and swapped the head and liner.

• Brand Name: MPACT HX PE ACETABULAR LINER
• Type of Device: PE ACETABULAR INSERT Ø 36
• 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, 6874 ; SZ 6874
• MDR Report Key: 6763308
• MDR Text Key: 81700693
• Report Number: 3005180920-2017-00438
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07630030812118
• UDI-Public: 07630030812118
• 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: Other
• Type of Report: Initial
• Report Date: 08/03/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 02/13/2022
• Device Catalogue Number: 01.32.3644HCT
• Device Lot Number: 168470
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/10/2017
• Initial Date FDA Received: 08/03/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/08/2017
• 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