MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT DOUBLE MOBILITY HC LINER Ø 46/22.2

Catalog Number 01.26.2246MHC

Device Problem Microbial Contamination of Device (2303)

Patient Problem Unspecified Infection (1930)

Event Date 07/04/2018

Event Type  Injury  

Manufacturer Narrative

Batch review performed on 26 july 2018: lot 177523: 72 items manufactured and released on 16 january 2018.Expiration date: 2023-01-01.No anomalies found related to the issue.To date, 39 items of the same lot have been already sold without any similar reported event.

Event Description

About 1 month after primary the surgeon revised the patient for a infection case.Liner swap.The surgery was completed successfully.

• Brand Name: MPACT DOUBLE MOBILITY HC LINER Ø 46/22.2
• Type of Device: DOUBLE MOBILITY HC 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: 7726664
• MDR Text Key: 115238188
• Report Number: 3005180920-2018-00567
• Device Sequence Number: 1
• Product Code: MEH
• UDI-Device Identifier: 07630030806834
• UDI-Public: 07630030806834
• 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: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2023
• Device Catalogue Number: 01.26.2246MHC
• Device Lot Number: 177523
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/04/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/16/2018
• 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 Age: 80 YR