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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 38AM5200
Device Problem Material Disintegration (1177)
Patient Problem Reaction (2414)
Event Type  Injury  
Event Description
Allegedly the patient was revised due to mom complications: a release of metal resulting in an increase of chromium and cobalt in the body.
 
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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 Key8676373
MDR Text Key147251415
Report Number3010536692-2019-00812
Device Sequence Number1
Product Code JDL
Combination Product (y/n)N
Reporter Country CodeBE
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/06/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model Number38AM5200
Device Catalogue Number38AM5200
Device Lot Number106382902
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date05/29/2019
Event Location No Information
Date Manufacturer Received05/29/2019
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: 06/06/2019 Patient Sequence Number: 1
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