MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. DELTA FEMORAL HEAD

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

Allegedly attended revision of an anca fit hip implanted 10+ years ago.Surgeon used long ar15 neck with bloball head and stryker cup.(b)(4).

• Brand Name: DELTA FEMORAL HEAD
• Type of Device: HEAD
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer (Section G): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 9871917
• MDR Text Key: 186556991
• Report Number: 3010536692-2019-01082
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: GB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/09/2019

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/10/2019
• Initial Date Manufacturer Received: 09/10/2019
• Initial Date FDA Received: 03/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR