Mako 180735-2Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00848486016555), received between Aug 29, 2018 and Nov 30, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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. 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.

• InjuryNov 30, 2021Unstable; Unstable

  RESTORES MCK MAKO ONLAY INSERT WAS SWAPPED FOR LARGER SIZE DUE TO INSTABILITY. WENT FROM 9MM INSERT TO 10MM.

  Patient problems: Joint Laxity

  MAUDE report 12892249 ↗
• InjuryJun 29, 2020Material Erosion; Insufficient Device Problem Information; Material Erosion; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT MAKO PARTIAL KNEE WAS REVISED DUE TO MEDIAL SUBSIDENCE OF THE FEMORAL COMPONENT, SUBSIDENCE OF THE TIBIAL COMPONENT, AND EXTREME POLY WEAR. SURGEON STATED THE OPINION THAT POLY WEAR/ DEBRIS WAS A CAUSE OR CONTRIBUTOR FOR FEMORAL SUBSIDENCE. PATIENT WAS REVISED TO A TOTAL KNEE. REP PROVIDED THE ORIGINAL USAGE REPORT AND EXPLANT PICTURES. THE DEVICES ARE ALLEGEDLY AVAILABLE FOR RETURN, OTHERWISE THE REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED.

  Patient problems: Injury; Insufficient Information

  MAUDE report 10207270 ↗
• InjuryAug 29, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  SURGEON REVISED A MAKO TIBIAL INSERT ORIGINALLY IMPLANTED ON (B)(6) 2018 DUE TO INFECTION, PERFORMING AN I&D.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7830556 ↗