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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE® A-CLASS® BFH® HEAD HIP COMPONENT

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MICROPORT ORTHOPEDICS INC. CONSERVE® A-CLASS® BFH® HEAD HIP COMPONENT Back to Search Results
Model Number 38AM-4800
Device Problem Insufficient Information (3190)
Patient Problem Reaction (2414)
Event Date 02/12/2019
Event Type  Injury  
Event Description
Allegedly the patient was experiencing mom complications: adverse local tissue response. The patient will be contacted by orthopedic clinic to set up the appointment to discuss revision. (b)(4). Additional information received from clinical on 05/31/2019. Allegedly the patient was revised due to mom complications: adverse local tissue response. Added the revision date.
 
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Brand NameCONSERVE® A-CLASS® BFH® HEAD
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 Key8670677
MDR Text Key147058726
Report Number3010536692-2019-00809
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 health professional
Reporter Occupation
Type of Report Initial
Report Date 06/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number38AM-4800
Device Catalogue Number38AM-4800
Device Lot Number068648142
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date05/31/2019
Event Location No Information
Date Manufacturer Received05/31/2019
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: 06/05/2019 Patient Sequence Number: 1
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