Evolution ETPLB6SRRecalls & reported problems
Microport Orthopedics Inc. · EVOLUTION®MP TIB SCREWLESS BF 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 M684ETPLB6SR1), received between Dec 28, 2020 and Mar 29, 2022 — classified as 4 injuries.
The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Break4
Patient problems
- Insufficient Information3
- No Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryMar 29, 2022Break; Break
ALLEGEDLY, TIBIAL BASE FRACTURED ON THE MEDIAL SIDE.
Patient problems: Insufficient Information
MAUDE report 13937793 ↗InjuryOct 6, 2021Break; Break
ALLEGEDLY, TIBIAL BASE PLATES ARE FRACTURED. PATIENT WILL BE REVISED.
Patient problems: Insufficient Information
MAUDE report 12583361 ↗InjuryJul 13, 2021Break; Break
ALLEGEDLY, PATIENT WAS REVISED DUE TO FRACTURED BASE PLATE. COMPONENTS NOT REVISED: PART ID: EFSRP6PR PRODUCT NAME: EVOLUTION®MP FEM CS/CR POROUS; PART ID: KPON32MB PRODUCT NAME: ADVANCE® ONLAY METAL BACK PATELLA 32MM.
Patient problems: Insufficient Information
MAUDE report 12158542 ↗InjuryDec 28, 2020Break; Break
ALLEGEDLY, THERE WAS A FRACTURED OF TIBIAL BASE PLATE ON THE RIGHT KNEE. COMPONENTS NOT REVISED: EVOLUTION FEMORAL EFSRP6PR LOT# 1750136. ADVANCE METAL BACK PATELLA KPON35MB LOT# 1743601.
Patient problems: No Information
MAUDE report 11082387 ↗
Other Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer devices
- ATTUNE 1512-14-050Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER106 reports
- ATTUNE 1504-40-205Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall53 reports
- ATTUNE 1504-40-105Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall46 reports
- ATTUNE 1547-06-001Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall37 reports
- ATTUNE 1513-12-060Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER72 reports
- Triathlon 5531-G-709-EHowmedica Osteonics Corp. · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall19 reports
- Triathlon 5521-B-300Howmedica Osteonics Corp. · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall19 reports
- Triathlon 5531-G-610-EHowmedica Osteonics Corp. · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall16 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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