• 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 MODULAR FEMORAL NECK; 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 MODULAR FEMORAL NECK; HIP COMPONENT Back to Search Results
Model Number PHA01224
Device Problem Break (1069)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 05/06/2020
Event Type  Injury  
Event Description
Allegedly, on (b)(6) 2020 the femoral neck of the device failed fracturing into two pieces, on that same date the device was surgically removed.During the revision procedure the doctor observed metallosis deep in the hip.(right hip).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PROFEMUR MODULAR FEMORAL NECK
Type of Device
HIP 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 Key10800636
MDR Text Key215032181
Report Number3010536692-2020-00686
Device Sequence Number1
Product Code LWJ
UDI-Device IdentifierM684PHA012241
UDI-PublicM684PHA012241
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Physician
Type of Report Initial
Report Date 11/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/06/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberPHA01224
Device Catalogue NumberPHA01224
Device Lot Number117500324
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/16/2020
Date Manufacturer Received10/16/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-