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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-4600
Device Problem Insufficient Information (3190)
Patient Problems Loss of Range of Motion (2032); Reaction (2414); Metal Related Pathology (4530)
Event Type  Injury  
Event Description
Allegedly, patient is suffering from mom complications to include: acetabular cup loose, elevated ion levels, impaired gait and failure of bony ingrowth. (left). Additional information received from litigation on 01/08/2019. Allegedly the patient was revised due to unknown mom complications. Added the explant 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 Key8301949
MDR Text Key134897797
Report Number3010536692-2019-00269
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 consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model Number38AM-4600
Device Catalogue Number38AM-4600
Device Lot Number029797064
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date01/08/2019
Event Location No Information
Date Manufacturer Received01/08/2019
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: 02/04/2019 Patient Sequence Number: 1
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