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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR(R) NECK HIP COMPONENT

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MICROPORT ORTHOPEDICS INC. PROFEMUR(R) NECK HIP COMPONENT Back to Search Results
Catalog Number PHAX-12XX
Device Problem Break (1069)
Patient Problem No Information (3190)
Event Type  Injury  
Event Description
Allegedly the patient was revised due to neck fracture.
 
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Brand NamePROFEMUR(R) NECK
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 Key6413662
MDR Text Key70242089
Report Number3010536692-2017-00381
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 health professional
Reporter Occupation
Type of Report Initial
Report Date 02/24/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/17/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberPHAX-12XX
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date02/24/2017
Event Location No Information
Date Manufacturer Received02/24/2017
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: 03/17/2017 Patient Sequence Number: 1
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