Mako 180736-1-ERecalls & reported problems
Mako Surgical Corp. · MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 6 - 8 MM · Class 2 · Implant
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327386127), received between Aug 1, 2023 and Oct 24, 2024 — classified as 3 injuries.
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
- Adverse Event Without Identified Device or Use Problem3
Patient problems
- Pain2
- Unspecified Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION OF PARTIAL MEDIAL KNEE REPLACEMENT TO TOTAL KNEE REPLACEMENT. PATIENT HAD PAIN IN MEDIAL COMPARTMENT.
Patient problems: Pain
MAUDE report 20521462 ↗InjuryApr 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DOCTOR REVISED A LEFT MEDIAL UNI ORIGINALLY DONE ON 1/6/2023 DUE TO PERSISTENT PAIN. NO ALLEGATIONS WERE MADE AGAINST THE IMPLANTS. SHE REVISED TO A PRIMARY TRIATHLON WITH UNIVERSAL BASEPLATE.
Patient problems: Pain
MAUDE report 19129482 ↗InjuryAug 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE FOLLOWING WAS REPORTED: PERFORMED AN I&D POLY SWAP OF A LEFT MEDIAL UNI DUE TO POSSIBLE INFECTION.
Patient problems: Unspecified Infection
MAUDE report 17438997 ↗
Other PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER devices
- LinkSymphoKnee 880-307/21WALDEMAR LINK GmbH & Co. KG · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 recalls2 reports
- Scorpio 73-3710Howmedica Osteonics Corp. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 recalls1 report
- Scorpio 73-3110Howmedica Osteonics Corp. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 recalls0 reports
- Arthrex® AR-503-TTTEArthrex, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall14 reports
- Arthrex® AR-503-TTTJArthrex, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall9 reports
- Arthrex® AR-503-TTTGArthrex, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall7 reports
- ENGAGE 1-10011-300Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall7 reports
- ENGAGE 1-10003-400Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall6 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.