Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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. GLADIATOR® G26 BIPOLAR; 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. GLADIATOR® G26 BIPOLAR; HIP COMPONENT Back to Search Results
Model Number GLJG-2643
Device Problem Disassembly (1168)
Patient Problem No Information (3190)
Event Date 01/10/2018
Event Type  Injury  
Manufacturer Narrative
This complaint will be updated once investigation is complete.Trends will be evaluated.
 
Event Description
Allegedly the surgeon performed bha on (b)(6) 2018.The surgeon found dissociation.So he performed tha as a revision.The patient had spent a normal life without falling.The surgeon has never experienced dissociation issue for over 20 years.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
GLADIATOR® G26 BIPOLAR
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 Key7348278
MDR Text Key102722624
Report Number3010536692-2018-00263
Device Sequence Number1
Product Code HWT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 02/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberGLJG-2643
Device Catalogue NumberGLJG-2643
Device Lot Number1697100
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date02/21/2018
Date Manufacturer Received02/21/2018
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;
Patient Age84 YR
-
-