ADVANCE® KIPS2410Recalls & reported problems
Microport Orthopedics Inc. · ADVANCE® II POST STAB TIBIAL INSERT SIZE 4 10mm · 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 M684KIPS24101), received between May 30, 2019 and Sep 8, 2025 — classified as 4 injuries.
The most frequently reported specific device problem is “Unstable” (2 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. 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
- Unstable2
- Insufficient Device Problem Information1
- Loss of Osseointegration1
Patient problems
- No Information2
- Osteolysis1
- Unspecified Infection1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjurySep 8, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION. SRNJR NUMBER: (B)(6). SIDE: L. GENDER: F.
Patient problems: Unspecified Infection
MAUDE report 22999149 ↗InjuryJun 23, 2020Unstable; Unstable
ALLEGEDLY, PATIENT WAS REVISED DUE TO INSTABILITY; REVISION NJR NUMBER: (B)(4); SIDE: L; PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.
Patient problems: No Information
MAUDE report 10184029 ↗InjuryJun 25, 2019Loss of Osseointegration; Loss of Osseointegration
ALLEGEDLY THE PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING FEMUR; ASEPTIC LOOSENING TIBIA; LYSIS TIBIA, REVISION NJR NUMBER: (B)(4), SIDE: R, PRIMARY ASA: P2-MILD DISEASE NOT INCAPACITATING.
Patient problems: Osteolysis
MAUDE report 8732934 ↗InjuryMay 30, 2019Unstable; Unstable
ALLEGEDLY, PATIENT WAS REVISED DUE TO INSTABILITY (LEFT). REVISION NJR NUMBER: (B)(4). PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.
Patient problems: No Information
MAUDE report 8656124 ↗
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.
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