Triathlon 5530-G-611Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613327050592), received between May 29, 2018 and Nov 11, 2022 — classified as 7 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. 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.

• InjuryNov 11, 2022Degraded; Unstable; Degraded; Unstable

  KNEE REVISION DUE TO INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 15785312 ↗
• InjuryJul 1, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT SHOWED SIGNS OF AN INFECTED LEFT TOTAL JOINT THAT WAS IMPLANTED 10 YEARS AGO.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 10216754 ↗
• InjuryOct 23, 2019Noise, Audible; Noise, Audible

  REP REPORTED THROUGH A PER THAT THE PATIENT HAS A REVISION "ANT PAIN, CLICKING." ALL AVAILABLE INFORMATION HAS BEEN SUBMITTED.

  Patient problems: Injury; Pain

  MAUDE report 9226668 ↗
• InjurySep 9, 2019Naturally Worn; Naturally Worn

  KNEE REVISION DUE TO POLY WEAR.

  Patient problems: Injury

  MAUDE report 8975672 ↗
• InjuryFeb 21, 2019Naturally Worn; Naturally Worn

  KNEE REVISION DUE TO POLY WEAR.

  Patient problems: Injury

  MAUDE report 8358488 ↗
• InjuryJul 27, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO POSSIBLE INFECTION. PARAMETERS OF INFECTION ARE NOT KNOWN. A 6X11 CR POLY WAS EXCHANGED FOR A 6X16 CS POLY.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7725697 ↗
• InjuryJun 18, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "PAIN IN ANTERIOR KNEE. POLY SWAP WHILE IN KNEE. ALL AVAILABLE INFORMATION SUBMITTED". EXPLANT PICTURES SHOW THAT THE PATELLAR IMPLANT SUFFERED VISIBLE DAMAGE. PATIENT WAS REVISED TO A 6/11 CR INSERT AND AN A35 X3 PATELLA.

  Patient problems: Injury; Pain

  MAUDE report 7611383 ↗
• MalfunctionMay 29, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  TRIATHLON TKA PROCEDURE WITH A SIZE 6 BASEPLATE. A SIZE 6 X 11 INSERT WAS PLACED ON THE BASEPLATE AND AN ATTEMPT TO SECURE IT INTO THE BASEPLATE WAS MADE. IT APPEARED TO BE FULLY SEATED, BUT WHEN THE INSERT WAS CHECKED IF LOCKED, THE SURGEON WAS ABLE TO LIFT THE INSERT OUT OF THE BASEPLATE. A SECOND 6 X 11 INSERT WAS OPENED AND THE SURGEON WAS ABLE TO SECURE THAT ONE TO THE BASEPLATE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7548337 ↗