MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. DYNASTY® BIOFOAM SHELL; HIP COMPONENT

Catalog Number PHAE-5506

Device Problem Unstable (1667)

Patient Problem No Code Available (3191)

Event Date 07/14/2016

Event Type  No Answer Provided  

Event Description

Allegedly the patient had hip replacement surgery on (b)(6) 2015.Revised biolox delta femoral head due to unknown reasons on (b)(6) 2015 and replaced with lineage transcend cocr femoral head.Revised dynasty biofoam shell and poly liner due to instability in (b)(6) 2016.Replaced with another manufacturers acetabular product.Date sponsor became aware of incident: (b)(6) 2016.

• Brand Name: DYNASTY® BIOFOAM SHELL
• Type of Device: HIP COMPONENT
• 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: 5974082
• MDR Text Key: 55558853
• Report Number: 3010536692-2016-01177
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/23/2016

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: Other
• Device Catalogue Number: PHAE-5506
• Device Lot Number: 15702411574202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 08/25/2016
• Initial Date Manufacturer Received: 08/25/2016
• Initial Date FDA Received: 09/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/24/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention