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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-3604
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Information (3190)
Event Date 08/14/2014
Event Type  Injury  
Manufacturer Narrative
This complaint will be updated once the investigation is complete. Trends will be evaluated.
 
Event Description
After intervention, patient continued with discomfort in the right hip. Patient was seen in the clinic in (b)(6) and had been during stretches with a therapist. An x-ray revealed he has a dislocated hip. He was admitted for a hip revision. Dynasty® biofoam shell, dynasty® a-class® poly liner, profemur® plus cocr modular neck, conserve® a-class® bfh head, and screw were revised (right). Sade # (b)(4).
 
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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 Key8392225
MDR Text Key137880683
Report Number3010536692-2019-00485
Device Sequence Number1
Product Code JDL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K051348
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 03/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model Number38AM-3604
Device Catalogue Number38AM-3604
Device Lot Number1484370
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/20/2019
Event Location No Information
Date Manufacturer Received02/20/2019
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: 03/05/2019 Patient Sequence Number: 1
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