Mako 180732-1Recalls & reported problems
Mako Surgical Corp. · Tibial Bearing Insert · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00848486016395), received between Jul 3, 2018 and Jan 14, 2022 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Dent in Material” (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.
Most reported problems
Device problems
- Dent in Material1
- Device Operates Differently Than Expected1
- Difficult to Insert1
- Installation-Related Problem1
- Noise, Audible1
- Scratched Material1
Patient problems
- Injury1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 14, 2022Difficult to Insert; Difficult to Insert
POLY HAS AN UNNATURAL LIP ON IT, WAS NOT ABLE TO PROPERLY SEAT IN IT. NO SURGICAL DELAY. CASE TYPE / APPLICATION: PKA (MICS). UPDATE: ANOTHER INSERT WAS ABLE TO BE INSERTED INTO THE BASEPLATE AND IMPLANTED INTO THE PATIENT WITHOUT ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13257062 ↗InjuryJul 3, 2018Dent in Material; Device Operates Differently Than Expected; Installation-Related Problem; Scratched Material; Noise, Audible; Dent in Material; Device Operates Differently Than Expected; Installation-Related Problem; Scratched Material; Noise, Audible
A SIZE 2 8 MM UNI ONLAY INSERT WAS IMPLANTED ON (B)(6) 2018. THE PATIENT COMPLAINED OF A SQUEAKING SOUND ON DEEP FLEXION. DURING A REVISION OF THE KNEE SURGEON EXPLANTED THE INSERT, AS IT WAS NOT LOCKED INTO THE BASEPLATE. THE PATIENT DOES CROSS FIT TRAINING AND IS VERY ACTIVE. WE PUT IN ANOTHER INSERT. PKA CASE.
Patient problems: Injury
MAUDE report 7659721 ↗
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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