MAUDE Adverse Event Report:

Device Problem Corroded (1131)

Patient Problem Host-Tissue Reaction (1297)

Event Type  Injury  

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Event Description

It was reported that the patient was revised approximately 2 years post initial right hip surgery due to adverse local tissue reaction.Head and liner were revised.Corrosion was found at the base of the femoral head.

• MDR Report Key: 7562779
• MDR Text Key: 109885033
• Report Number: 0001822565-2018-02895
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1