• 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. ADVANCE UNI TIBIA; KNEE 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. ADVANCE UNI TIBIA; KNEE COMPONENT Back to Search Results
Model Number KTNPUN40
Device Problem Loss of Osseointegration (2408)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
 
Event Description
Allegedly, patient was revised due to aseptic loosening tibia.Revision njr number: (b)(4).Side: r.Primary asa: p3 - incapacitating systemic disease.
 
Manufacturer Narrative
This incident is a duplicate event of the manufacturer report number: (b)(4).Please void this report.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ADVANCE UNI TIBIA
Type of Device
KNEE COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key12447991
MDR Text Key277740896
Report Number3010536692-2021-00510
Device Sequence Number1
Product Code HRY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 10/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberKTNPUN40
Device Catalogue NumberKTNPUN40
Device Lot Number3341822
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date08/24/2021
Date Manufacturer Received08/24/2021
Patient Sequence Number1
-
-