Triathlon 5517-F-701Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613327041002), received between May 30, 2017 and Oct 20, 2025 — classified as 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Unstable” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• InjuryOct 20, 2025Unstable; Device Dislodged or Dislocated; Unstable; Device Dislodged or Dislocated

  NO NEW INFORMATION.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 23334681 ↗
• InjuryFeb 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED BECAUSE THE PATIENT WAS TIGHT IN FLEXION. A 7 CR FEMUR AND 7X9 CS INSERT WERE EXCHANGED.

  Patient problems: Loss of Range of Motion

  MAUDE report 16382812 ↗
• InjuryJul 2, 2019Unstable; Unstable

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO" ONE YEAR STATUS POST CEMENTLESS LEFT TOTAL KNEE ARTHROPLASTY WITH ANTERIOR-POSTERIOR INSTABILITY."

  Patient problems: Injury

  MAUDE report 8754248 ↗
• InjuryMay 22, 2019Unstable; Unstable

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "UNSTABLE LEFT TOTAL KNEE REPLACEMENT".

  Patient problems: Injury

  MAUDE report 8632951 ↗
• InjuryApr 3, 2019Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO "LEFT TOTAL KNEE JOINT REPLACEMENT UNSTABLE SECONDARY TO TOTAL KNEE JOINT REPLACEMENT."

  Patient problems: Injury

  MAUDE report 8479879 ↗
• MalfunctionMar 5, 2019Fitting Problem; Insufficient Device Problem Information; Fitting Problem; Insufficient Device Problem Information

  THIS PI IS FOR THE REPORTED JOINT REPLACEMENT IMPLANT. PRIMARY PROCEDURE, BILATERAL MAKO TKA. IT WAS REPORTED THAT WHEN THE CUTS WERE MADE FOR THE PATIENT'S LEFT FEMUR, THE LEFT PRESS-FIT FEMORAL COMPONENT DID NOT SIT FLUSH ON THE ANTERIOR CHAMFER. THE DEVICE WAS SITTING PROUD BY ABOUT 1MM TO 1.5MM. IT IS UNKNOWN IF THIS DISCREPANCY WAS PRESENT DURING TRIALING, IT WAS NOT NOTICED OR REPORTED BY THE SURGEON. SURGEON DECIDED TO USE A CEMENTED STEM INSTEAD. AFTER IMPLANTATION OF THE LEFT KNEE CONSTRUCT, ATTENTION WAS TURNED TO THE RIGHT KNEE. WHEN THE FEMORAL CUT WAS MADE, SURGEON TESTED THE ORIGINAL LEFT PRESS-FIT FEMORAL COMPONENT (THERE WAS NO INTENTION TO IMPLANT IT), AND IT SAT FLUSH. A RIGHT PRESS-FIT FEMORAL COMPONENT WAS IMPLANTED. SURGERY WAS COMPLETED WITH A 5 TO 10 MINUTE DELAY IN SURGERY WITH USE OF TOURNIQUET. SURGEON IS A MAKO CONSULTANT AND IS EXPERIENCED WITH THE SYSTEM. ALL CUTS WERE MADE ACCORDING TO THE PLAN. PATIENT'S BONE QUALITY WAS REPORTED AS VERY GOOD, VERY HARD BONE. REP DOES NOT KNOW WHICH OF THE FACILITY'S TWO ROBOTS WERE USED FOR THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8391623 ↗
• MalfunctionFeb 28, 2018Packaging Problem; Packaging Problem

  OPENED AN IMPLANT IN THEATRE AND THE IMPLANT PACKAGING WAS BROKEN - AS WE HANDED THE IMPLANT TO THE SCRUB NURSE WE THEN REALIZED IT HAD BEEN CRACKED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7304411 ↗
• MalfunctionMay 30, 2017Break; Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  THE IMPLANT SHELL IS DAMAGED WHILE THE OUTER BOX IS NOT IMPAIRED.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 6597506 ↗