ADVANCE® KIMP412LRecalls & reported problems
Microport Orthopedics Inc. · ADVANCE® II MEDIAL PIVOT TIBIAL INSERT SZ 4 LEFT 12mm · 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 M684KIMP412L1), received between Dec 24, 2019 and Feb 22, 2024 — classified as 4 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
- Insufficient Device Problem Information2
- Device Dislodged or Dislocated1
- Malposition of Device1
- Unstable1
Patient problems
- Arthritis1
- Loss of Range of Motion1
- Pain1
- Unspecified Infection1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryFeb 22, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
ALLEGEDLY, DISLOCATION/SUBLUXATION/PROGRESSIVE ARTHRITIS. SIDE: L. REVISION NJR: (B)(6). GENDER: F. EXPLANTED: FEMORAL COMPONENT, TIBIAL COMPONENT, TIBIAL LINER.
Patient problems: Arthritis
MAUDE report 18760403 ↗InjuryJun 26, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION. COMPONENT NOT REVISED: ADVANCE PRIMARY FEMORAL SIZE 4 LEFT NONPOROUS PRODUCT ID: KFTCNP4L, LOT ID: 1715036. ADVANCE II COCR TIBIA BASE NONPOROUS SZ 4+ PRODUCT ID: KTCCNP41, LOT ID: 1704308. REVISION NJR NUMBER: (B)(4). SIDE: L. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.
Patient problems: Unspecified Infection
MAUDE report 10200703 ↗InjuryJun 22, 2020Unstable; Malposition of Device; Unstable; Malposition of Device
ALLEGEDLY, PATIENT WAS REVISED DUE TO INSTABILITY; MALALIGNMENT; STIFFNESS COMPONENT NOT REVISED: PATELLA. REVISION NJR NUMBER: 4290175. SIDE: L . PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.
Patient problems: Loss of Range of Motion
MAUDE report 10179923 ↗InjuryDec 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGEDLY THE PATIENT WAS REVISED DUE TO PAIN AND XRAYS THAT SHOWED LOOSENING OF IMPLANTS. LEFT KNEE.
Patient problems: Pain
MAUDE report 9516034 ↗
Other Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer devices
- ATTUNE 1506-00-005Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER589 reports
- ATTUNE 1506-00-004Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER580 reports
- JOURNEY 74012812Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER502 reports
- JOURNEY 74011856Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER438 reports
- PERSONA™ 42-5099-094-00Zimmer, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER406 reports
- JOURNEY 74011857Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER388 reports
- ATTUNE 1506-00-007Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER288 reports
- ATTUNE 1506-00-003Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER271 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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