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U.S. Department of Health and Human Services

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

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MICROPORT ORTHOPEDICS INC. CONSERVE® TOTAL A-CLASS® HEAD HIP COMPONENT Back to Search Results
Model Number 38AM-XXXX
Device Problem Break (1069)
Patient Problem No Information (3190)
Event Type  Injury  
Manufacturer Narrative
This complaint will be updated once investigation is complete. Trends will be evaluated.
 
Event Description
Per article by dowding and beaule, et al. , j arthrop. 2018: a patient suffered failure because of a femoral neck fracture.
 
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Brand NameCONSERVE® TOTAL A-CLASS® 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 Key7652820
MDR Text Key112837875
Report Number3010536692-2018-00869
Device Sequence Number1
Product Code JDL
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial
Report Date 06/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number38AM-XXXX
Device Catalogue Number38AM-XXXX
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/01/2018
Event Location No Information
Date Manufacturer Received06/01/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 06/29/2018 Patient Sequence Number: 1
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