ADVANCE® KTCCNP30Recalls & reported problems
Microport Orthopedics Inc. · ADVANCE® II CoCr TIBIAL BASE NONPOROUS SZ 3 STANDARD · Class 2 · Implant
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 19
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI M684KTCCNP301), received between Mar 24, 2020 and Apr 19, 2024 — classified as 19 injuries, 1 malfunction.
The most frequently reported specific device problem is “Loss of Osseointegration” (6 reports).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Loss of Osseointegration6
- Unstable6
- Insufficient Device Problem Information3
- Fracture2
- Adverse Event Without Identified Device or Use Problem1
- Appropriate Device Problem Term/Code Not Available1
- Break1
- Malposition of Device1
Patient problems
- Insufficient Information6
- No Information5
- Bone Fracture(s)4
- Failure of Implant2
- Unspecified Infection2
- Arthritis1
- Osteolysis1
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
InjuryApr 19, 2024Loss of Osseointegration; Loss of Osseointegration
ALLEGEDLY, THE PATIENT WAS DIAGNOSED WITH RADIOLOGY. EVIDENT LOOSENING OF THE PROSTHESIS WAS DETECTED, THE TIBIAL BASE WAS REPLACED. THE INITIAL IMPLANTATION WAS PERFORMED IN 2015. FIRST REVISION: IT WAS DETECTED SHORTLY AFTER IMPLANTATION THAT THERE WAS INFECTION AND AN INSERT CHANGE WAS PERFORMED. PE WAS NOT FIRMLY ATTACHED TO THE TIBIAL COMPONENT AS INTENDED, BUT BECAME DETACHED FROM IT. AS A RESULT, THERE WAS WEAR OF THE UNDERSIDE OF THE INSERT WITH POLYETHYLENE GRANULOMAS. THERE WERE POLYETHYLENE GRANULOMAS THROUGHOUT THE JOINT AND COMPLETE LOOSENING OF THE PROSTHESIS. THE JOINT WAS RECONSTRUCTED WITH A COMPLEX COUPLED, MODULAR, STEM-GUIDED PROSTHESIS AND ALL GRANULOMAS WERE REMOVED IN APPROXIMATELY 3 HOURS OF REVISION SURGERY. THE EXPLANTS WERE GIVEN TO THE PATIENT: PRODUCT ID: KIMP312R ADVANCE® II MEDIAL PIVOT TIBIAL INSERT SZ 3 RIGHT 12MM / LOT NO.: 1687317/ QTY: (B)(4). PRODUCT ID: KFTCNP3R ADVANCE® PRIMARY FEMORAL SIZE 3 RIGHT NONPOROUS / LOT NO.: 1707334/ QTY: (B)(4). PRODUCT ID: KTCCNP30 ADVANCE® II COCR TIBIAL BASE NONPOROUS SZ 3 STANDARD/ LOT NO.: 1644600/ QTY:(B)(4).
Patient problems: Insufficient Information
MAUDE report 19146657 ↗InjuryFeb 28, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGEDLY, LYSIS FEMUR/PERIPROSTHETIC FRACTURE. SIDE: R. REVISION NJR: (B)(4). GENDER: F. EXPLANTED: FEMORAL COMPONENT, TIBIAL COMPONENT, TIBIAL LINER.
Patient problems: Bone Fracture(s)
MAUDE report 18796538 ↗InjuryFeb 28, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGEDLY, OTHER SIDE: R REVISION NJR: (B)(4). GENDER: F EXPLANTED: ALL
Patient problems: Insufficient Information
MAUDE report 18796334 ↗InjuryMay 29, 2023Loss of Osseointegration; Loss of Osseointegration
ALLEGEDLY, PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING TIBIA/INFECTION/LYSIS TIBIA REVISION NJR NUMBER: (B)(6). SIDE: L, PRIMARY ASA: P1 - FIT AND HEALTHY.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 17016855 ↗InjuryApr 17, 2023Loss of Osseointegration; Loss of Osseointegration
ALLEGEDLY, PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING TIBIA. REVISION NJR NUMBER: 5063407. SIDE: L. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING. PRODUCTS NOT REVISED: PRODUCT ID: LOT NUMBER: QTY: KPONTP41 1471010 1.
Patient problems: Insufficient Information
MAUDE report 16751573 ↗InjuryDec 22, 2022Loss of Osseointegration; Loss of Osseointegration
ALLEGEDLY, PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING TIBIA REVISION NJR NUMBER: SIDE: L PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.
Patient problems: Failure of Implant
MAUDE report 16035381 ↗InjuryAug 4, 2022Unstable; Migration; Unstable; Migration
ALLEGEDLY, PATIENT WAS REVISED DUE TO INSTABILITY / MALALIGNMENT. REVISION NJR NUMBER: (B)(4), SIDE: L, PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.
Patient problems: Insufficient Information
MAUDE report 15169433 ↗InjuryMay 11, 2022Break; Break
ALLEGEDLY, PATIENT WAS REVISED DUE TO PERI-PROSTHETIC FRACTURE. REVISION NJR NUMBER: (B)(4), SIDE: L , PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.
Patient problems: Insufficient Information
MAUDE report 14360852 ↗InjuryApr 6, 2022Unstable; Unstable
ALLEGEDLY, PATIENT WAS REVISED DUE TO INSTABILITY. REVISION NJR NUMBER: (B)(4), SIDE: L , PRIMARY ASA: P3 - INCAPACITATING SYSTEMIC DISEASE.
Patient problems: Insufficient Information
MAUDE report 14028546 ↗InjuryJun 14, 2021Loss of Osseointegration; Loss of Osseointegration
ALLEGEDLY, PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING FEMUR/ ASEPTIC LOOSENING TIBIA REVISION NJR NUMBER: (B)(4). SIDE: R, PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING. (B)(6) REFERENCE NO: (B)(4).
Patient problems: Failure of Implant
MAUDE report 11992533 ↗InjuryMay 12, 2021Fracture; Appropriate Device Problem Term/Code Not Available
ALLEGEDLY, PATIENT WAS REVISED DUE TO PERI-PROSTHETIC FRACTURE REVISION NJR NUMBER: (B)(4). SIDE: R. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING MHRA REFERENCE NO: (B)(4).
Patient problems: Bone Fracture(s)
MAUDE report 11812547 ↗InjuryApr 13, 2021Adverse Event Without Identified Device or Use Problem
ALLEGEDLY, PATIENT WAS REVISED DUE TO PERI-PROSTHETIC FRACTURE. REVISION NJR NUMBER: (B)(4). SIDE: R. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING. MHRA REFERENCE NO: (B)(4).
Patient problems: Bone Fracture(s)
MAUDE report 11658273 ↗InjuryApr 13, 2021Fracture
ALLEGEDLY, PATIENT WAS REVISED DUE TO PERI-PROSTHETIC FRACTURE. REVISION NJR NUMBER: (B)(6). SIDE: L. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING. (B)(4).
Patient problems: Bone Fracture(s)
MAUDE report 11657778 ↗InjuryDec 4, 2020Unstable; Loss of Osseointegration; Unstable; Loss of Osseointegration
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).
Patient problems: Arthritis
MAUDE report 10944831 ↗InjuryNov 3, 2020Unstable; Unstable
ALLEGEDLY, PATIENT WAS REVISED DUE TO INSTABILITY. REVISION NJR NUMBER: 4524345. SIDE: L. PRIMARY ASA: P1 - FIT AND HEALTHY. MHRA REFERENCE NO: (B)(4).
Patient problems: No Information
MAUDE report 10777212 ↗InjuryJun 29, 2020Malposition of Device; Malposition of Device
ALLEGEDLY, PATIENT WAS REVISED DUE TO MALALIGNMENT AND STIFFNESS. REVISION NJR NUMBER: (B)(4); SIDE: L; PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.
Patient problems: No Information
MAUDE report 10207021 ↗InjuryJun 29, 2020Unstable; Unstable
ALLEGEDLY, PATIENT WAS REVISED DUE TO INSTABILITY. COMPONENT NOT REVISED: ADVANCE ONLAY ALL POLY PATELLA 35MM TRIPEG PRODUCT ID: KPONTP35 LOT ID: 1759570. REVISION NJR NUMBER: 4387320. SIDE: R. PRIMARY ASA: P3 - INCAPACITATING SYSTEMIC DISEASE.
Patient problems: No Information
MAUDE report 10206252 ↗InjuryJun 29, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION. REVISION NJR NUMBER: 4478100. SIDE: L. PRIMARY ASA: P3 - INCAPACITATING SYSTEMIC DISEASE.
Patient problems: Unspecified Infection
MAUDE report 10205993 ↗InjuryJun 26, 2020Unstable; Unstable
ALLEGEDLY, PATIENT WAS REVISED DUE TO INSTABILITY. REVISION NJR NUMBER: (B)(4); SIDE: R; PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.
Patient problems: No Information
MAUDE report 10203498 ↗MalfunctionMar 24, 2020Material Deformation; Material Deformation
ALLEGEDLY, WHEN POSITIONING THE INSERT, IT WOULD NOT SEAT INTO THE TIBIAL BASE AND THIS GENERATED A TIBIAL BASE DEFORMITY.
Patient problems: No Information
MAUDE report 9873359 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.