Mako 180733-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00848486016449), received between Sep 14, 2017 and Aug 10, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 10, 2026Fracture

  Performing a revision of a uni knee to total knee procedure. Retrieval and removal of old tibia implant revealed a broken portion of the posterior polyethylene insert. Previous knee a mako PKA performed on (b)(6) 2019. Revision was for advancement of arthritis and it was unknown there was any implant issue until the implant was removed. Total knee was implanted with no issues.

  Patient problems: Arthritis

  MAUDE report 50195937 ↗
• InjuryOct 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DR. PERFORMED AN I&D WITH POLY SWAP OF A RIGHT MEDIAL KNEE ORIGINALLY DONE (B)(6) 2021 DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 12705398 ↗
• MalfunctionSep 14, 2017Device Operates Differently Than Expected; Material Deformation; Device Operates Differently Than Expected; Material Deformation

  SURGEON ATTEMPTED TO PUT THE POLY IN AND IT WOULD NOT LOCK. AFTER EXAMINING IT, THE BASE OF IT WAS NOT FLAT AND THEREFORE WOULDN'T LOCK INTO THE BASE PLATE. SURGICAL DELAY OF 5 TO 7 MINUTES. CASE TYPE LEFT PKA.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6865529 ↗