Evolution EFSRN4PRRecalls & reported problems
Microport Orthopedics Inc. · EVOLUTION®MP FEM CS/CR NON-POR SIZE 4 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 M684EFSRN4PR1), received between Oct 23, 2019 and Sep 18, 2025 — classified as 5 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
- Insufficient Device Problem Information1
- Loss of Osseointegration1
- Packaging Problem1
- Unstable1
Patient problems
- Insufficient Information2
- Joint Dislocation1
- Loss of Range of Motion1
- No Information1
- Unspecified Infection1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjurySep 18, 2025Unstable; Unstable
ALLEGEDLY, PATIENT WAS REVISED DUE TO INSTABILITY. SRNJR NUMBER: (B)(6). SIDE: R. GENDER: F.
Patient problems: Insufficient Information
MAUDE report 23089986 ↗InjuryMay 16, 2024Packaging Problem; Packaging Problem
ALLEGEDLY, A PRODUCT OF EFSRN3PL LOT MP1982097 IN THE PACKAGE OF EFSRN4PR LOT MP1982170. ADDITIONAL INFORMATION RECEIVED ON 04/28/2024: THE 2 LOTS HAVE (B)(4) OF EACH GOT INTO CHINA MARKET, (B)(4) HAVE BEEN IMPLANTED WITHOUT ISSUE, ALL THE REST OF THE PARTS HAVE BEEN RETURNED TO SUZHOU.
Patient problems: Insufficient Information
MAUDE report 19336858 ↗InjuryMay 11, 2022Appropriate Device Problem Term/Code Not Available
ALLEGEDLY, PATIENT WAS REVISED DUE TO STIFFNESS. COMPONENT NOT REVISED: PRODUCT: ADVANCE ONLAY ALL POLY PATELLA 35MM TRIPEG PRODUCTID: KPONTP35 LOT#:1804141 QTY:1, REVISION NJR NUMBER: (B)(4), SIDE: R, PRIMARY ASA: P1 - FIT AND HEALTHY.
Patient problems: Loss of Range of Motion
MAUDE report 14360925 ↗InjuryJun 8, 2020Loss of Osseointegration; Loss of Osseointegration
ALLEGEDLY, PATIENT WAS REVISED DUE TO LOOSENING. (B)(6).
Patient problems: No Information
MAUDE report 10129159 ↗InjuryOct 23, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION.
Patient problems: Joint Dislocation; Unspecified Infection
MAUDE report 9227072 ↗
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.