Mako 180734-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00848486016494), received between Sep 10, 2019 and Nov 4, 2025 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryNov 4, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  AFTER THE CLOSED WOUND, A POST-SURGERY X-RAY REVEALED AN INTRA-ARTICULAR FOREIGN BODY. THE INSERT WAS REMOVED AND THE FOREIGN BODY WAS EXTRACTED. IT WAS DAMAGED DURING REMOVAL, SO IT WAS REPLACED WITH A NEW ONE.

  Patient problems: Insufficient Information

  MAUDE report 23472322 ↗
• InjuryFeb 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS PER PATIENT'S VOICEMAIL: PATIENT STATED HE HAD A TKA ON (B)(6) 2019. PATIENT STATED HE IS UNABLE TO WALK. UPDATE AS PER PATIENT: PATIENT STATED HE HAD A PKA ON (B)(6) 2019. PATIENT WAS TAKEN TO THE RECOVERY ROOM AND WAS TOLD HE HAD TO SEE A PT. HE ASKED THE NURSE TO USE THE BATHROOM BECAUSE HE COULDN'T GET OUT OF BED, HE WAS TOLD HE COULDN'T USE THE BATHROOM AS HE HAD TO DO PT FIRST. THE PATIENT ASKED FOR A PERCOCET FOR PAIN AND HE WAS TOLD HE COULDN'T GET ONE UNTIL AFTER PT. THE PHYSICAL THERAPIST ALSO TOLD HIM THAT HE COULDN'T USE THE RESTROOM UNTIL HE HAD PT. THE PHYSICAL THERAPIST ASSISTED HIM TO THE BATHROOM AFTER PT WAS DONE. WHILE THE PHYSICAL THERAPIST WAS ASSISTING, HE LET GO OF THE GATE BELT AND THE PATIENT FELL ON THE LEG THAT WAS OPERATED ON. THE PHYSICAL THERAPIST ASSISTED THE PATIENT TO THE BED AND TOLD THE PATIENT THAT HE WAS GOING TO REPORT THE FALL AND GET IN TOUCH WITH THE PHYSICIANS ASSISTANT. 1-2 HOURS LATER THE PHYSICIAN ASSISTANTS CAME TO CHECK ON THE PATIENT AND THE PATIENT TOLD THEM OF THE FALL. THE PHYSICIANS CHECKED THE WOUND AND THE PATIENT WAS DISCHARGED. THE PATIENT WAS TOLD IF HE EXPERIENCES ANY SYMPTOMS TO CALL THEM. PATIENT STATED THAT HIS WIFE WA

  Patient problems: Fall; Inadequate Osseointegration; Pain; Unspecified Infection

  MAUDE report 13601299 ↗
• InjuryOct 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DR. REVISED A RIGHT MAKO MEDIAL UNI TO A TOTAL KNEE TRIATHLON DUE TO PAIN. NO EVIDENCE OF LOOSENING OR ALLEGATIONS AGAINST THE COMPONENTS. UPDATE 10/SEPTEMBER/2021: REP PROVIDED PRIMARY AND REVISION USAGE SHEETS AND REPORTED THAT NO FURTHER INFORMATION IS DUE TO HOSPITAL POLICY. REVISION SURGERY WAS COMPLETED ROBOTICALLY.

  Patient problems: Pain

  MAUDE report 12580124 ↗
• InjuryNov 5, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  WRONG SIZE ONLAY TIBIAL INSERT WAS INSERTED INTO PATIENT. I WRONGLY GRABBED A SIZE 4 INSERT INSTEAD OF SIZE 5 AND SHOWED BOXES TO NURSE BEFORE OPENING, SURGEON REFUSED TO LOOK AT BOXES TO CONFIRM. THIS RESULTED IN WRONG SIZE BEING PUT IN PATIENT. BOTH ASSISTANT AND SURGEON DIDN¿T PICK UP THE SIZE DIFFERENCE ON INSERTION AND PROCEEDED WITH CLOSING THE INCISION. WHILE ASSISTANT STITCHED UP, SURGEON UNSCRUBBED & LOOKED AT PATIENT STICKERS REALIZING WRONG SIZES ON LABELS. SURGEON RESCRUBBED & I GRABBED CORRECT SIZE WHICH WAS INSERTED AND WRONG ONE DISCARDED. SURGICAL DELAY OF 10 MINUTES TO CHANGE THE INSERT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10791537 ↗
• InjuryMar 13, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT LATERAL PKA WAS REVISED DUE TO INFECTION. ALL COMPONENTS WERE REMOVED AND A SPACER WAS PLACED. REP PROVIDED THE REVISION USAGE SHEET AND CONFIRMED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9829417 ↗
• MalfunctionOct 30, 2019Fitting Problem; Fitting Problem

  DIFFICULTY WITH INSERTION OF THE SIZE 4 8MM UNI INSERT. ENDED UP INSERTING A NEW POLY SAME DIMENSIONS WITHOUT INCIDENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9255052 ↗
• InjurySep 10, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS CONVERTED FROM A PKA TO A TKA DUE TO PAIN (POSSIBLE CAUSE OR CONTRIBUTOR TO PAIN UNKNOWN). A MAKO PKA WAS CONVERTED TO A TRIATHLON TKA.

  Patient problems: Injury; Pain

  MAUDE report 8980990 ↗