• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR TAPERED HIP STEM HIP COMPONENT

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MICROPORT ORTHOPEDICS INC. PROFEMUR TAPERED HIP STEM HIP COMPONENT Back to Search Results
Model Number PHA00411
Device Problem Insufficient Information (3190)
Patient Problems Bone Fracture(s) (1870); No Information (3190)
Event Type  Injury  
Manufacturer Narrative
This event will be updated when investigation is complete.
 
Event Description
Allegedly, patient scheduled to be revised due to unknown complications.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePROFEMUR TAPERED HIP STEM
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 Key8727998
MDR Text Key148984455
Report Number3010536692-2019-00835
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 health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 07/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberPHA00411
Device Catalogue NumberPHA00411
Device Lot Number067439174
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date05/28/2019
Event Location No Information
Date Manufacturer Received05/28/2019
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: 06/24/2019 Patient Sequence Number: 1
-
-