Evolution EIS6S14RRecalls & reported problems
Microport Orthopedics Inc. · EVOLUTION® MP™ CS INSERT SIZE 6 STANDARD 14MM 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 M684EIS6S14R1), received between Feb 9, 2021 and Mar 29, 2023 — 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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Appropriate Device Problem Term/Code Not Available1
- Insufficient Device Problem Information1
- Unstable1
Patient problems
- Unspecified Infection3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMar 29, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGEDLY, THE KNEE HAD AN INFECTION, SO THE DOCTOR CHANGED THE POLY.
Patient problems: Unspecified Infection
MAUDE report 16637225 ↗InjuryFeb 17, 2021Unstable; Appropriate Device Problem Term/Code Not Available
ALLEGEDLY, THE PATIENT UNDERWENT R TKR ON (B)(6) 2019. REVISED ON (B)(6) 2021 DUE TO INFECTION. INSERT REPLACED FOR A SIZE 17, EIS6S17R. AUSTRALIA- C1057. ADDITIONAL INFORMATION RECEIVED FROM (B)(6) ON 02/17/2021: THIS PATIENT WAS REVISED FOR INSTABILITY MID FLEXION AND NOT INFECTION, IT WAS REPORTED INCORRECTLY.
Patient problems: Unspecified Infection
MAUDE report 11337815 ↗InjuryFeb 9, 2021Adverse Event Without Identified Device or Use Problem
ALLEGEDLY, THE PATIENT WAS REVISED DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 11302530 ↗
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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