ADVANCE® KPONTP38Recalls & reported problems
Microport Orthopedics Inc. · ADVANCE® ONLAY ALL-POLY PATELLA 38mm TRI-PEG · Class 2 · Implant
All models of ADVANCE (147)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI M684KPONTP381), received between Dec 16, 2019 and Jan 22, 2025 — classified as 3 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
- Loss of Osseointegration1
Patient problems
- Unspecified Infection2
- Inflammation1
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJan 22, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION. SRNJR NUMBER: (B)(6). SIDE: L. GENDER: M.
Patient problems: Unspecified Infection
MAUDE report 21209513 ↗InjuryOct 9, 2023Loss of Osseointegration; Loss of Osseointegration
ALLEGEDLY, PATIENT UNDERWENT L TKR ON (B)(6) 2015. PATELLA AND TIBIAL INSERT REVISED ON (B)(6) 2023 AND REPLACED WITH IMPLANTS OF THE SAME SIZE. THE SURGEON SUSPECTED THE PATELLA WAS NEVER SEATED CORRECTLY WHEN IMPLANTED. IT WAS HANGING OFF THE SIDE OF THE PATELLA. TIBIAL INSERT REPLACED JUST IN CASE WHILE THE KNEE WAS OPEN. (B)(4).
Patient problems: Insufficient Information
MAUDE report 17894283 ↗InjuryDec 16, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGEDLY, PT UNDERWENT BILATERAL TKR ON (B)(6) 2014 AT (B)(6) HOSPITAL. ON (B)(6) 2014, THE PATIENTS C-REACTIVE PROTEIN (CPR) LEVEL WAS RECORDED AS HIGH AS 234MG/L. ON (B)(6)2018, THE PATIENTS CPR LEVEL WAS RECORDED AS 284MG/L. SURGEON ADVISED THAT THE PATIENT WOULD REQUIRE 2 SURGERIES, OR LIFE-LONG ANTIBIOTICS IN ORDER TO TREAT THE CONDITION. (B)(6).
Patient problems: Inflammation; Unspecified Infection
MAUDE report 9473024 ↗
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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