MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT DM DOUBLE MOBILITY HC LINER Ø 58/28; DOUBLE MOBILITY LINER

Catalog Number 01.26.2858MHC

Device Problem Microbial Contamination of Device (2303)

Patient Problem Unspecified Infection (1930)

Event Date 10/09/2018

Event Type  Injury  

Manufacturer Narrative

Batch review performed on (b)(6) 2018.Lot 164476: 50 items manufactured and released on (b)(6) 2016.Expiration date: 2021-09-26.No anomalies found related to the problem.To date, 34 items of the same lot have been already sold without any similar reported event.

Event Description

I&d and liner revision performed 34 days after primary surgery due to signs of infection, the pathogen is unknown.

• Brand Name: MPACT DM DOUBLE MOBILITY HC LINER Ø 58/28
• Type of Device: DOUBLE MOBILITY LINER
• 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: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8137076
• MDR Text Key: 129448234
• Report Number: 3005180920-2018-00977
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 07630030807442
• UDI-Public: 07630030807442
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092265
• 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: 11/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/26/2021
• Device Catalogue Number: 01.26.2858MHC
• Device Lot Number: 164476
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/09/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/12/2016
• 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