ADVANCE® KIRV417SRecalls & reported problems
Microport Orthopedics Inc. · ADVANCE® II REVISION CCK INSERT SIZE 4 STANDARD 17mm · Class 2 · Implant
All models of ADVANCE (147)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M684KIRV417S1), received between Jun 5, 2025 and Jun 5, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 5, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGEDLY, PATIENT UNDERWENT TKA IN THE UK, DATE UNKNOWN. REVISED ON (B)(6) 2025 DUE TO INFECTION. TIBIAL INSERT REVISED WITH ANOTHER OF THE SAME SIZE. INSERT SUPPLIED UNDER SAS CATEGORY B, TGA APPROVAL REF (B)(4). NON-REVISED PRODUCTS: PORDUCT ID: KTTINP40 ADVANCE® II MODULAR TITANIUM TIBIAL BASE SZ 4 STD NONPOROUS/ LOT NO.: 1559477/ QTY: 1. PORDUCT ID: KSP16140 ADVANCE® CANAL FILLING STEM EXTENSION 17MM X 140MM/ LOT NO.: 1409427/ QTY: 1. PORDUCT ID: KFCCNP4R ADVANCE® REVISION FEMORAL SIZE 4 RIGHT NONPOROUS/ LOT NO.: 1542396/ QTY: 1. PORDUCT ID: KSP14100 ADVANCE® CANAL FILLING STEM EXTENSION 15MM X 100MM/ LOT NO.: 1409425/ QTY: 1. PORDUCT ID: KPONTP35 ADVANCE® ONLAY ALL-POLY PATELLA 35MM TRI-PEG/ LOT NO.: 1580890/ QTY: 1 AUSTRALIA (B)(4).
Patient problems: Unspecified Infection
MAUDE report 22154451 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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