Mako 180734-1-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613327385984), received between Mar 12, 2020 and May 11, 2026 — classified as 8 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: DR. MARCHAND PERFORMED AN I&D OF A RIGHT MEDIAL MCK KNEE DUE TO INFECTION AND SWAPPED THE INSERT. ORIGINAL SURGERY WAS (B)(6) 26 AT ORI.

  Patient problems: Unspecified Infection

  MAUDE report 25135312 ↗
• InjuryMay 31, 2024Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO PAIN. A MAKO RIGHT MEDIAL UNI KNEE WAS CONVERTED TO A TRIATHLON TKA. INTRA-OPERATIVELY, SURGEON REPORTED THAT THE INSERT LOOKED DISCOLORED/ PITTED. SURGEON WOULD LIKE INVESTIGATION RESULTS. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Pain

  MAUDE report 19436344 ↗
• InjuryMar 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: PATIENT STATES ON (B)(6) 2024: "I AM 6 WEEKS OUT ON MONDAY ON MY PARTIAL KNEE REPLACEMENT. I SAW THE DR YESTERDAY. PLEASED WITH EVERYTHING BUT I'M AT A STANDSTILL WITH MY RANGE OF MOTION. SO A WEEK FROM THURSDAY WITH INSURANCE APPROVAL HE IS GOING TO DO A "MANIPULATION UNDER ANESTHESIA" (MUA) ON MY KNEE. I WILL HAVE PT FRIDAY, MONDAY AND TUESDAY. THEN, A FEW MORE AND I'LL BE DONE. I SEE HIM AGAIN ON THE 26TH."

  Patient problems: Loss of Range of Motion

  MAUDE report 19002744 ↗
• InjuryJul 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DR. REVISED A RIGHT MEDIAL UNI KNEE TO A PRIMARY ALL-POLY CS TRIATHLON DUE TO INFECTION.

  Patient problems: Post Operative Wound Infection; Unspecified Infection

  MAUDE report 17379419 ↗
• InjuryMay 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PERFORMED AN I&D OF A RIGHT MEDIAL UNI KNEE DUE TO INFECTION. REPLACED THE INSERT, WAS REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 17000549 ↗
• InjuryJun 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT MEDIAL PKA WAS REVISED. AS REPORTED: "REVISION W/ POLY EXCHANGE. INFECTION." REP PROVIDED PRIMARY AND REVISION USAGE AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 14878732 ↗
• InjuryJun 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISED AND PERFORMED AN I&D OF A RIGHT KNEE AND REPLACED THE TIBIAL INSERT OF AN MCK MEDIAL UNI FOR POSSIBLE INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 14753256 ↗
• InjuryMar 12, 2020Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  AS REPORTED: "PATIENT CAME IN ON (B)(6) 2020 TO SEE DR. FOR LIMITED MOTION IN HER LEFT KNEE. SHE MISSED A COUPLE OF HER THERAPY APPOINTMENTS PRIOR. LIMITED MOTION OF 5-90 DEGREES. PATIENT WANTED A MANIPULATION. CLOSED MANIPULATION UNDER ANESTHESIA OCCURRED ON (B)(6) 2020."

  Patient problems: Injury; Loss of Range of Motion

  MAUDE report 9824814 ↗