Mako 180733-1-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327385892), received between Mar 23, 2021 and Jan 6, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJan 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S KNEE WAS REVISED. AS REPORTED: "THE PT HAD SOME WOUND DRAINAGE THAT MIGHT INDICATE INITIAL INFECTION. DR. WANTED TO DO AN I&D &,SWAP OUT THE POLY INSERT WITH THE IDENTICAL SIZE THAT WAS REMOVED." REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 21081314 ↗
• InjuryNov 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SWAPPED A LEFT LATERAL TIBIAL MCK INSERT DUE TO NEED OF ARTHROTOMY REPAIR. NO ALLEGATIONS AGAINST IMPLANT MADE.

  Patient problems: Insufficient Information

  MAUDE report 18136259 ↗
• InjuryNov 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: PERFORMED AN I&D OF A RIGHT MEDIAL UNI DUE TO POSSIBLE INFECTION. HE SWAPPED THE TIBIAL INSERT.

  Patient problems: Unspecified Infection

  MAUDE report 18070533 ↗
• InjuryOct 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  I&D TIBIAL INSERT EXCHANGE DUE TO INFECTION. RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15555898 ↗
• InjuryAug 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PERFORMED AN I&D ON A RIGHT LATERAL MAKO UNI KNEE DUE TO INFECTION. FIRST I&D WAS DONE (B)(6) 2021." REP PROVIDED USAGE SHEETS FOR PRIMARY AND SUBSEQUENT REVISIONS AND CONFIRMED NO FURTHER INFORMATION IS AVAILABLE DUE TO HOSPITAL POLICY.

  Patient problems: Unspecified Infection

  MAUDE report 15144657 ↗
• InjuryMar 23, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A POLY SWAP WAS PERFORMED ON THE PATIENT'S LEFT KNEE DUE TO INFECTION. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 11553245 ↗