MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE TOTAL A-CLASS 48MM; HIP COMPONENT

Model Number 38AC-4800

Device Problem Material Disintegration (1177)

Patient Problem Reaction (2414)

Event Date 09/24/2018

Event Type  Injury  

Event Description

Allegedly the patient is experiencing mom complications.Subject was seen (b)(6) 2018 for study visit.The left tha is asymptomatic.The metal ion labs were elevated, the mars mri showed possible altr.The pi would like to follow up at visit 2 with repeat labs and mri.The neck and stem are not microport products.(b)(4) additional information: allegedly patient was seen for study visit 2 on (b)(6) 2019 and pi is recommending revision surgery due to adverse local tissue reaction.(b)(4) additional information on 02/20/2020: revision surgery confirmed on (b)(6) 2020 due to adverse local tissue reaction , the large femoral stem and neck sleeve were remove.

• Brand Name: CONSERVE TOTAL A-CLASS 48MM
• 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: 10264760
• MDR Text Key: 206348182
• Report Number: 3010536692-2020-00477
• Device Sequence Number: 1
• Product Code: JDL
• UDI-Device Identifier: M68438AC48001
• UDI-Public: M68438AC48001
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/13/2020

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
• Device Model Number: 38AC-4800
• Device Catalogue Number: 38AC-4800
• Device Lot Number: 090120834410
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/20/2020
• Initial Date Manufacturer Received: 02/20/2020
• Initial Date FDA Received: 07/13/2020
• 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: 65 YR
• Patient Weight: 82