Evolution EFSRN6PRRecalls & reported problems
Microport Orthopedics Inc. · EVOLUTION®MP FEM CS/CR NON-POR SIZE 6 PRIMARY RIGHT · Class 2 · Implant
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI M684EFSRN6PR1), received between Jun 25, 2020 and Mar 14, 2025 — classified as 5 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information4
- Loss of Osseointegration1
- Material Too Rigid or Stiff1
Patient problems
- Unspecified Infection2
- Hypersensitivity/Allergic reaction1
- Insufficient Information1
- Loss of Range of Motion1
- Osteolysis1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryMar 14, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGEDLY, POTENTIAL ALLERGIC REACTION.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 21605441 ↗InjuryNov 22, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGEDLY, PATIENT HAVING PROBLEMS SINCE HAD THE RIGHT KNEE REPLACEMENT DONE.
Patient problems: Insufficient Information
MAUDE report 20758939 ↗InjuryJun 26, 2024Loss of Osseointegration; Insufficient Device Problem Information; Loss of Osseointegration; Insufficient Device Problem Information
ALLEGEDLY, PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING TIBIA/INFECTION/LYSIS TIBIA. SRNJR NUMBER: 5118495. SIDE: R. GENDER: F.
Patient problems: Osteolysis; Unspecified Infection
MAUDE report 19620460 ↗InjurySep 23, 2022Material Too Rigid or Stiff
ALLEGEDLY, PATIENT UNDERWENT R TKR ON (B)(6) 2019 WITH NATIVE PATELLA PRESERVED. PATELLA RESURFACED ON (B)(6) 2021 DUE TO STIFFNESS. NONE OF THE COMPONENTS WERE REVISED. (B)(6).
Patient problems: Loss of Range of Motion
MAUDE report 15469739 ↗InjuryJun 25, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION. REVISION NJR NUMBER: 2928216. SIDE: R. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.
Patient problems: Unspecified Infection
MAUDE report 10196837 ↗
Other Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer devices
- ATTUNE 1506-00-005Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER589 reports
- ATTUNE 1506-00-004Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER580 reports
- JOURNEY 74012812Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER502 reports
- JOURNEY 74011856Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER438 reports
- PERSONA™ 42-5099-094-00Zimmer, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER406 reports
- JOURNEY 74011857Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER388 reports
- ATTUNE 1506-00-007Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER288 reports
- ATTUNE 1506-00-003Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER271 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.