Evolution ETPLB6SLRecalls & reported problems
Microport Orthopedics Inc. · EVOLUTION®MP TIB SCREWLESS BF SIZE 6 STANDARD 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 M684ETPLB6SL1), received between Oct 7, 2021 and Apr 4, 2023 — classified as 4 injuries.
The most frequently reported specific device problem is “Break” (3 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
- Break3
- Loss of Osseointegration2
Patient problems
- Insufficient Information3
- Pain1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryApr 4, 2023Break; Break
ALLEGEDLY, THE REVISION WAS DUE TO FRACTURED TIBIAL BASE.
Patient problems: Insufficient Information
MAUDE report 16678364 ↗InjuryJun 20, 2022Loss of Osseointegration; Loss of Osseointegration
ALLEGEDLY, 7 MONTHS POST OP HAD INCREASED WEIGHT BEARING PAIN. 44 MONTHS POST OP- NO COMPLAINT JUST VISIT TO DOCTOR BUT CAN SEE SOME LOOSENING. ON (B)(6) 2022 PATIENT WAS IN PAIN, HYPERFLEX OCCURRED IN SHOW DUE TO OTHER ISSUES COMPONENTS HAVE NOT BEEN REVISED. THIS WAS A PROPHECY CASE (B)(4).
Patient problems: Pain
MAUDE report 14749850 ↗InjuryNov 2, 2021Break; Loss of Osseointegration; Break; Loss of Osseointegration
ALLEGEDLY, REVISED FOR BROKEN LOOSE TIBIA AND FEMUR EASILY REMOVED.
Patient problems: Insufficient Information
MAUDE report 12738746 ↗InjuryOct 7, 2021Break; Break
ALLEGEDLY, TIBIAL BASE PLATES ARE FRACTURED. PATIENT WILL BE REVISED.
Patient problems: Insufficient Information
MAUDE report 12590368 ↗
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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