ADVANCE® KTCCNP31Recalls & reported problems
Microport Orthopedics Inc. · ADVANCE® II CoCr TIBIAL BASE NONPOROUS SZ 3+ · Class 2 · Implant
All models of ADVANCE (147)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI M684KTCCNP311), received between Jun 26, 2020 and Oct 15, 2024 — classified as 4 injuries.
The most frequently reported specific device problem is “Fracture” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture1
- Improper or Incorrect Procedure or Method1
- Insufficient Device Problem Information1
- Unstable1
Patient problems
- Insufficient Information2
- Bone Fracture(s)1
- Unspecified Infection1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryOct 15, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
ALLEGEDLY, INCORRECT IMPLANT CONFIGURATION USED. AN ADVANCE FEMUR STATURE IMPLANT WAS USED IN COMBINATION WITH AN ADVANCE PLUS SIZE TIBIA. SURGEON HAS BEEN MADE AWARE AND PATIENT IS BEING MONITORED.
Patient problems: Insufficient Information
MAUDE report 20455970 ↗InjuryApr 17, 2023Unstable; Unstable
ALLEGEDLY, PATIENT WAS REVISED DUE TO INSTABILITY/WEAR OF POLYETHYLENE COMPONENT. REVISION NJR NUMBER: 5052592. SIDE: L. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.
Patient problems: Insufficient Information
MAUDE report 16751367 ↗InjuryAug 4, 2022Fracture
ALLEGEDLY, PATIENT WAS REVISED DUE TO PERI-PROSTHETIC FRACTURE REVISION NJR NUMBER: (B)(4). SIDE: R. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING. COMPONENT NOT REVISED: PRODUCT: ADVANCE II MEDIAL PIVOT TIBIA INSERT SZ 3 RIGHT 10MM PRODUCT ID: KIMP310R LOT # : 125303897 QTY: 1.
Patient problems: Bone Fracture(s)
MAUDE report 15169315 ↗InjuryJun 26, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION. REVISION NJR NUMBER: 4356191; SIDE: L; PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.
Patient problems: Unspecified Infection
MAUDE report 10199911 ↗
Other Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer devices
- R3 71363077Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER461 reports
- NA 71364009Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER174 reports
- JOURNEY 74012416Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER163 reports
- JOURNEY 74012415Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER163 reports
- JOURNEY 74012414Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER129 reports
- GENESIS II 71440194Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER114 reports
- GENESIS II 71440842Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER113 reports
- JOURNEY 74018901Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER106 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page