Evolution EIS4S12RRecalls & reported problems
Microport Orthopedics Inc. · EVOLUTION® MP™ CS INSERT SIZE 4 STANDARD 12MM RIGHT · 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 M684EIS4S12R1), received between Sep 25, 2019 and Nov 7, 2023 — 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information2
- Unstable2
Patient problems
- Pain3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryNov 7, 2023Unstable; Unstable
InjuryOct 25, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGEDLY, PATIENT UNDERWENT R TKR ON (B)(6) 2016 AND L TKR, DATE UNKNOWN, WITH BOTH PATELLAE PRESERVED. BOTH KNEES WERE REVISED ON (B)(6) 2023 DUE TO PATELLA PAIN. PATELLAE ADDED AND INSERTS WERE REPLACED EVEN THOUGH THE IN-SITU ONES WERE IN PRISTINE CONDITION. RIGHT KNEE. SURGICAL SPECIALTIES REF (B)(4).
Patient problems: Pain
MAUDE report 18007482 ↗InjurySep 25, 2019Unstable; Insufficient Device Problem Information; Unstable; Insufficient Device Problem Information
ALLEGEDLY, THE LINER WAS INCREASED FROM 12MM TO 14MM DUE TO ANTERIOR KNEE PAIN. THE ACTION TAKEN WAS TO RESURFACE THE PATELLA. THE INCREASED POLY SIZE TO SZ4 14MM WAS TO ADDRESS SLIGHT LIGAMENT LAXITY IN FLEXION OVER TIME.
Patient problems: Pain
MAUDE report 9119751 ↗
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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