Evolution ETPKN4SLRecalls & reported problems
Microport Orthopedics Inc. · EVOLUTION® MP TIB KEELED NONPOR SIZE 4 STANDARD LEFT · Class 2 · Implant
All models of Evolution (125)
Data updated Oct 16, 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 M684ETPKN4SL1), received between Oct 18, 2022 and Nov 11, 2024 — classified as 3 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
- Loss of Osseointegration1
- Malposition of Device1
Patient problems
- Failure of Implant1
- Insufficient Information1
- Pain1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryNov 11, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
InjuryMar 31, 2023Loss of Osseointegration; Loss of Osseointegration
ALLEGEDLY, PATIENT UNDERWENT L TKR ON (B)(6) 2018, PRIMARY SURGEON HAS SINCE RETIRED. REVISED ON (B)(6) 2023 DUE TO TIBIAL LOOSENING. CEMENT AND IMPLANT WERE SOLID, BUT PATIENT REPORTED PAIN. REVISED WITH EVOLUTION REVISION TIBIAL BASE AND A THICKER INSERT.
Patient problems: Pain
MAUDE report 16656121 ↗InjuryOct 18, 2022Malposition of Device; Malposition of Device
ALLEGEDLY, PATIENT WAS REVISED DUE TO MALALIGNMENT REVISION NJR NUMBER: 4908238, SIDE: L , PRIMARY ASA: P3 - INCAPACITATING SYSTEMIC DISEASE. PRODUCT NO REVISED: PRODUCT ID: EFSRN3PL, LOT: 1785763, QTY: 1.
Patient problems: Failure of Implant
MAUDE report 15626985 ↗
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 74012415Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER163 reports
- JOURNEY 74012416Smith & 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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