Evolution ETPKN6SRRecalls & reported problems
Microport Orthopedics Inc. · EVOLUTION® MP TIB KEELED NONPOR SIZE 6 STANDARD RIGHT · 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 M684ETPKN6SR1), received between Jun 25, 2020 and Mar 14, 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
- Insufficient Device Problem Information2
- Loss of Osseointegration2
Patient problems
- Insufficient Information2
- Hypersensitivity/Allergic reaction1
- Unspecified Infection1
Recent adverse event reports
The 4 most recent of 4 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 21605598 ↗InjuryOct 6, 2021Loss of Osseointegration; Loss of Osseointegration
ALLEGEDLY, SYSTEM SEEMS TO BE LOOSENING DERIVED FROM RHEUMATISM. IMPLANT REVISION WITH TMO FOR TIBIAL LOOSENING. SINCE THE INSERT DID NOT COME OFF DURING REMOVAL, IT WAS REMOVED INTEGRALLY WITH THE BASE PLATE. (B)(4).
Patient problems: Insufficient Information
MAUDE report 12583454 ↗InjuryJul 7, 2021Loss of Osseointegration; Loss of Osseointegration
ALLEGEDLY, PATIENT UNDERWENT R TKR ON (B)(6) 2018. REVISED ON (B)(6) 2021 DUE TO LOOSENING OF THE TIBIA. REVISING SURGEON WAS OFFERED MPO'S TIBIAL REVISION OPTION AS THE FEMUR WAS NOT LOOSE AND COULD HAVE STAYED IN PLACE. SURGEON DECIDED TO REVISE ALL COMPONENTS WITH ANOTHER MANUFACTURER'S FULL REVISION SYSTEM. (B)(6). (B)(4).
Patient problems: Insufficient Information
MAUDE report 12132690 ↗InjuryJun 25, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION. REVISION (B)(4). SIDE: R. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.
Patient problems: Unspecified Infection
MAUDE report 10196831 ↗
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 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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