Evolution EFPSN5PLRecalls & reported problems
Microport Orthopedics Inc. · EVOLUTION®MP FEM PS NON POR SIZE 5 PRIMARY LEFT · Class 2 · Implant
All models of Evolution (125)
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 M684EFPSN5PL1), received between Feb 16, 2021 and Feb 16, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Loss of Osseointegration” (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.
Most reported problems
Device problems
- Loss of Osseointegration1
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.
InjuryFeb 16, 2021Loss of Osseointegration; Loss of Osseointegration
ALLEGEDLY, WHEN THE INSERT WAS REMOVED DURING THE TKA REVISION OPERATION, THERE WERE CLEAR SIGNS OF LIPID ABSORPTION AND PARTICIPATION IN THE REMOVED INSERT, CAUSING DELAMINATION AND PITTING. PHYSICIAN'S FINDINGS: SINCE THIS IS AN EARLY PHENOMENON WITHIN 2 YEARS AFTER SURGERY, THERE ARE CONCERNS ABOUT PRODUCT PROBLEMS AND LONG-TERM CLINICAL RESULTS. ADDITIONAL INFORMATION RECEIVED ON 01/22/2021: ALLEGEDLY, THE PATIENT WAS REVISED DUE TO LOOSENING OF BOTH THE FEMUR AND TIBIAL COMPONENTS AS WELL AS INFECTION. ADDITIONAL INFORMATION RECEIVED ON 01/24/2021: PRIMARY OPERATION DATE IS (B)(6) 2018. ADDITIONAL INFORMATION RECEIVED ON 01/27/2021: PRODUCT ID'S AND LOT NUMBERS FOR TIBIAL AND FEMUR REVISED COMPONENTS WERE OBTAINED. ADDITIONAL INFORMATION RECEIVED ON 04/29/2021: REVISION FACILITY AND SURGEON CONFIRMATION. (B)(4).
Patient problems: Unspecified Infection
MAUDE report 11335020 ↗
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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