Evolution ETPKN7SRRecalls & reported problems
Microport Orthopedics Inc. · EVOLUTION® MP TIB KEELED NONPOR SIZE 7 STANDARD RIGHT · Class 2 · Implant
All models of Evolution (125)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M684ETPKN7SR1), received between Dec 16, 2019 and Feb 21, 2024 — classified as 2 injuries.
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
- Unstable1
Patient problems
- Inflammation1
- Loss of Range of Motion1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 21, 2024Unstable; Unstable
ALLEGEDLY, INSTABILITY/STIFFNESS SIDE: R REVISION NJR: (B)(4). GENDER: M EXPLANTED: FEMORAL COMPONENT, TIBIAL COMPONENT, TIBIAL LINER.
Patient problems: Loss of Range of Motion
MAUDE report 18749883 ↗InjuryDec 16, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGEDLY, THE PATIENT UNDERWENT BILATERAL TOTAL KNEE REPLACEMENT 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 9473152 ↗
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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