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U.S. Department of Health and Human Services

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

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MICROPORT ORTHOPEDICS INC. CONSERVE TOTAL A-CLASS 48MM HIP COMPONENT Back to Search Results
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.
 
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Brand NameCONSERVE TOTAL A-CLASS 48MM
Type of DeviceHIP 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 Key10264760
MDR Text Key206348182
Report Number3010536692-2020-00477
Device Sequence Number1
Product Code JDL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 07/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number38AC-4800
Device Catalogue Number38AC-4800
Device Lot Number090120834410
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/20/2020
Event Location No Information
Date Manufacturer Received02/20/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 07/13/2020 Patient Sequence Number: 1
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