Evolution EIS4P12RRecalls & reported problems
Microport Orthopedics Inc. · EVOLUTION® MP™ CS INSERT SIZE 4+ 12MM 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 M684EIS4P12R1), received between Jun 7, 2019 and May 4, 2021 — classified as 2 injuries.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (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
- Loose or Intermittent Connection1
Patient problems
- No Information1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 4, 2021Adverse Event Without Identified Device or Use Problem
ALLEGEDLY, PATIENT UNDERWENT RIGHT TKR ON (B)(6) 2018. THE PATIENT HAS BEEN ADMITTED WITH AN INFECTION IN ANOTHER AREA OF THE BODY ON (B)(6) 2021. THE INFECTION THEN SPREAD TO THE KNEE. PATIENT REVISED ON (B)(6) 2021, WASHOUT PERFORMED, INSERT REPLACED WITH ONE OF THE SAME SIZE. (B)(4).
Patient problems: Unspecified Infection
MAUDE report 11773267 ↗InjuryJun 7, 2019Loose or Intermittent Connection; Loose or Intermittent Connection
ALLEGEDLY THE KNEE HAD LOOSENED UP. HAD A LOT OF VARUS/VALGUS LAXITY AND HYPER-EXTENSION. TOOK OUT A 12MM INSERT AND REPLACED IT WITH A 17MM INSERT.
Patient problems: No Information
MAUDE report 8679983 ↗
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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