Mako 180735-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00848486016548), received between May 1, 2017 and Sep 17, 2019 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  DR. PERFORMED AN I&D WITH A TIBIAL INSERT EXCHANGE OF A MAKO LEFT MEDIAL UNI KNEE DUE TO INFECTION. ORIGINAL SURGERY WAS (B)(6) 2019. UPDATE 20/AUGUST/2019 (B)(4): REP PROVIDED PRIMARY AND REVISION USAGE SHEETS AND REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9075201 ↗
• InjuryAug 5, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  DR. PERFORMED AN I&D WITH POLY EXCHANGE ON A MAKO MEDIAL UNI KNEE ORIGINALLY DONE ON (B)(6) 2019. DUE TO INFECTION. NO ISSUES WITH THE COMPONENT WAS FOUND.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8860012 ↗
• InjuryMay 17, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE DOCTOR PERFORMED AN I&D POLY EXCHANGE ON A MAKO PARTIAL KNEE DUE TO INFECTION. ORIGINAL SURGERY WAS (B)(6) 2018. THE I&D WAS PERFORMED ON THE (B)(6) 2018. ON THE 22/APRIL/2019 THE REP PROVIDED IMPLANT/ USAGE SHEETS FOR PRIMARY AND SUBSEQUENT TWO REVISIONS AND REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8619526 ↗
• InjuryJan 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  I&D WITH A TIBIAL INSERT EXCHANGE PERFORMED ON (B)(6) 2018 OF A MAKO PKA ORIGINALLY DONE ON (B)(6) 2018 DUE TO INFECTION.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8274354 ↗
• InjuryNov 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DR. (B)(6) REVISED A MAKO UNI KNEE TO A PRIMARY CEMENTLESS TKA DUE TO PAIN. (B)(6) OBSERVED THE PATELLAFEMORAL JOINT DISEASE PROGRESSED A BIT. IMPLANTS WERE NOT LOOSE.

  Patient problems: Injury; Pain

  MAUDE report 8065747 ↗
• MalfunctionJun 19, 2017Mechanical Problem; Device Damaged by Another Device; Positioning Problem; Mechanical Problem; Device Damaged by Another Device; Positioning Problem

  THE COMPANY REPRESENTATIVE REPORTED THAT THE SURGEON HAD TROUBLE IMPLANTING A MAKO PARTIAL KNEE. THIS WAS A PRIMARY SURGERY ON THE LEFT KNEE. AN UPDATE ON (B)(6) 2017 REPORTED THAT THE SURGEON HAD TROUBLE GETTING THE IMPLANT LINED UP CORRECTLY AND COULDN'T GET IT TO SNAP DOWN IN PLACE. NEITHER OF THE INSERTS WERE IMPLANTED AND A THIRD POLY WAS BROUGHT IN FROM OUR OFFICE AND WAS IMPLANTED. THERE WAS A SURGICAL DELAY OF APPROXIMATELY 35-40 MINUTES WHILE WE WAITED ON A THIRD POLY TO BE DELIVERED TO THE HOSPITAL FROM OUR OFFICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6652451 ↗
• MalfunctionJun 19, 2017Mechanical Problem; Device Damaged by Another Device; Positioning Problem; Mechanical Problem; Device Damaged by Another Device; Positioning Problem

  THE COMPANY REPRESENTATIVE REPORTED THAT THE SURGEON HAD TROUBLE IMPLANTING A MAKO PARTIAL KNEE. THIS WAS A PRIMARY SURGERY ON THE LEFT KNEE. AN UPDATE ON (B)(6) 2017 REPORTED THAT THE SURGEON HAD TROUBLE GETTING THE IMPLANT LINED UP CORRECTLY AND COULDN'T GET IT TO SNAP DOWN IN PLACE. NEITHER OF THE INSERTS WERE IMPLANTED AND A THIRD POLY WAS BROUGHT IN FROM OUR OFFICE AND WAS IMPLANTED. THERE WAS A SURGICAL DELAY OF APPROXIMATELY 35-40 MINUTES WHILE WE WAITED ON A THIRD POLY TO BE DELIVERED TO THE HOSPITAL FROM OUR OFFICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6652383 ↗
• InjuryMay 1, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  SURGEON DID AN I&D WITH AN INSERT SWAP OF THE LEFT KNEE DONE AS A MAKO MEDIAL ORIGINALLY ON (B)(6) 2017.

  Patient problems: Injury

  MAUDE report 6533481 ↗