Mako 180735-1-ERecalls & reported problems
Mako Surgical Corp. · MAKO X3 UNI ONLAY TIBIAL INSERT SIZE 5 - 8 MM · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327386028), received between Apr 20, 2021 and May 4, 2026 — classified as 7 injuries.
The most frequently reported specific device problem is “Degraded” (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. 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
- Adverse Event Without Identified Device or Use Problem5
- Degraded1
- Insufficient Device Problem Information1
- Osseointegration Problem1
Patient problems
- Unspecified Infection5
- Inadequate Osseointegration1
- Insufficient Information1
- Pain1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryMay 4, 2026Adverse Event Without Identified Device or Use Problem
THE FOLLOWING INFORMATION WAS PROVIDED: I&D OF A LM PKA WITH AN MCK TIBIAL INSERT EXCHANGE DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 25072041 ↗InjuryNov 27, 2025Degraded; Osseointegration Problem; Degraded; Osseointegration Problem
NO NEW INFORMATION.
Patient problems: Inadequate Osseointegration; Insufficient Information
MAUDE report 23666031 ↗InjuryMay 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY THE COMPANY REPRESENTATIVE THAT PATIENT DEVELOP INFECTION FROM POST PKR DUE TO UNKNOWN REASONS.
Patient problems: Unspecified Infection
MAUDE report 21940832 ↗InjuryFeb 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
I&D AND POLY SWAP OF A MEDIAL MCK RIGHT KNEE DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 21343160 ↗InjuryOct 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISED A LEFT MEDIAL TIBIAL INSERT DUE TO A FLOATING LOOSE BODY THAT CAUSED THE PATIENT PAIN. REMOVED THE LOOSE BODY AND PUT A NEW TIBIAL INSERT IN. NO ALLEGATIONS AGAINST THE IMPLANT MADE.
Patient problems: Pain
MAUDE report 17907251 ↗InjuryJan 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DR. PERFORMED AN I&D AND REVISED A MAKO TIBIAL INSERT THAT WAS ORIGINALLY DONE BY DR. ON (B)(6) 2021 DUE TO INFECTION. RIGHT KNEE.
Patient problems: Unspecified Infection
MAUDE report 13221431 ↗InjuryApr 20, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
DR. PERFORMED AN I&D POLY EXCHANGE ON A RIGHT MAKO MEDIAL UNI ORIGINALLY DONE (B)(6) 2021 DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 11694932 ↗
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 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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