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. ADVANCE II COCR TIBIAL BASE NONPOROUS SZ 3 STANDA; 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 II COCR TIBIAL BASE NONPOROUS SZ 3 STANDA; KNEE COMPONENT Back to Search Results
Model Number KTCCNP30
Medical Device Problem Codes Unstable (1667); Loss of Osseointegration (2408)
Health Effect - Clinical Code Arthritis (1723)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
 
Event or Problem Description
Allegedly, patient was revised due to aseptic loosening tibia; instability; wear of polyethylene component; progressive arthritis.Revision njr number: (b)(4).Side: r; primary asa: p2 - mild disease not incapacitating; mhra reference no: (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ADVANCE II COCR TIBIAL BASE NONPOROUS SZ 3 STANDA
Common Device Name
KNEE COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
MDR Report Key10944831
Report Number3010536692-2020-00730
Device Sequence Number642089
Product Code HRY
UDI-Device IdentifierM684KTCCNP301
UDI-PublicM684KTCCNP301
Combination Product (Y/N)N
Initial Reporter CountryGB
PMA/510(K) Number
K960617
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2011
Device Explanted Year2020
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 01/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Other
Device Model NumberKTCCNP30
Device Catalogue NumberKTCCNP30
Device Lot Number0111286040
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/16/2020
Initial Date Received by Manufacturer 11/16/2020
Supplement Date Received by Manufacturer11/16/2020
Initial Report FDA Received Date12/04/2020
Supplement Report FDA Received Date01/29/2021
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
-
-