Evolution EFSRN4PLRecalls & reported problems
Microport Orthopedics Inc. · EVOLUTION®MP FEM CS/CR NON-POR SIZE 4 PRIMARY LEFT · Class 2 · Implant
All models of Evolution (125)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI M684EFSRN4PL1), received between May 10, 2021 and Jan 22, 2025 — classified as 4 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
- Adverse Event Without Identified Device or Use Problem2
- Insufficient Device Problem Information2
Patient problems
- Unspecified Infection2
- Hypersensitivity/Allergic reaction1
- Insufficient Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJan 22, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION. SRNJR NUMBER: (B)(6). SIDE: L. GENDER: M.
Patient problems: Unspecified Infection
MAUDE report 21209451 ↗InjuryNov 11, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
InjuryMar 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ALLEGEDLY, A PATIENT IMPLANTED WITH MPO COMPONENTS ON JUNE 21ST HAS EXPERIENCED A RASH ON HER SKIN. THE PATIENT HAS SALMONELLA AND SHE HAS HAD THREE SURGERIES AND CANNOT GET RID OF THE RASH. THEREFORE, THE SURGEON IS REQUESTING FOR THE METAL AND PLASTIC COMPOSITION OF THE COMPONENTS TO DETERMINE IF THE PATIENT IS EXPERIENCING AN ALLERGIC REACTION TO THE IMPLANT.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 13861937 ↗InjuryMay 10, 2021Adverse Event Without Identified Device or Use Problem
ALLEGEDLY, PATIENT WENT TO REVISION DUE TO INFECTION. (B)(6).
Patient problems: Unspecified Infection
MAUDE report 11803351 ↗
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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