Triathlon 5532-G-711Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07613327046281), received between Sep 12, 2017 and Mar 31, 2026 — classified as 13 injuries.

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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2026Unstable

  AS PART OF AN INVESTIGATOR INITIATED STUDY, IT WAS INDICATED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO INSTABILITY AND PATELLOFEMORAL ARTHRITIS. THE INSERT WAS REVISED AND THE PATIENT'S NATIVE PATELLA WAS RESURFACED.

  Patient problems: Arthritis; Joint Laxity

  MAUDE report 24746550 ↗
• InjuryJul 17, 2025Mechanical Problem; Mechanical Problem

  AS PART OF AN INVESTIGATOR INITIATED STUDY, A SPREADSHEET WAS PROVIDED INDICATING THAT AN MUA WAS PERFORMED ON THE PATIENT'S RIGHT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 22538816 ↗
• InjuryJul 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS PART OF AN INVESTIGATOR INITIATED STUDY, A SPREADSHEET WAS PROVIDED INDICATING THAT AN MUA WAS PERFORMED ON THE PATIENT'S RIGHT KNEE.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 22508726 ↗
• InjuryJul 2, 2025Unstable; Unstable

  AS PART OF AN INVESTIGATOR INITIATED STUDY, A SPREADSHEET WAS PROVIDED INDICATING THAT THE PATIENT'S LEFT KNEE UNDERWENT AN MUA AT AN UNKNOWN DATE. POST (PRIMARY)-OP COMPLICATION REPORTED AS 'INSTABILITY.' MUA WAS PERFORMED ON (B)(6) 2014.

  Patient problems: Joint Laxity

  MAUDE report 22381935 ↗
• InjuryOct 4, 2024Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  THIS PI IS FOR LEFT KNEE. PATIENT HAD BILATERAL REVISION FOR UNKNOWN REASONS.

  Patient problems: Insufficient Information

  MAUDE report 20375016 ↗
• InjuryAug 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED. AS REPORTED: "THE PATIENT HAD A POLY SWAP ON HIS RIGHT KNEE. NO IMPLANTS RETURNED PER HOSPITAL POLICY AND ALL INFORMATION THE HOSPITAL HAD ON THIS PATIENT WAS INCLUDED." SPOKE TO REP, WHO CONFIRMED REASON FOR REVISION WAS INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 15205724 ↗
• InjuryAug 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A STAGE 1 REVISION WAS PERFORMED ON THE PATIENT'S RIGHT KNEE DUE TO INFECTION. ALL COMPONENTS WERE REMOVED AND A SPACER WAS PLACED.

  Patient problems: Unspecified Infection

  MAUDE report 15137395 ↗
• InjuryMay 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A STAGE 1 REVISION WAS PERFORMED ON THE PATIENT'S RIGHT KNEE DUE TO INFECTION. ALL COMPONENTS WERE REMOVED AND A SPACER WAS PLACED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 11861547 ↗
• InjuryFeb 14, 2020Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED. AS REPORTED BY REP: "UNSTABLE TOTAL LEFT KNEE. DID POLY SWAP."

  Patient problems: Injury

  MAUDE report 9712709 ↗
• InjuryFeb 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  POSTOPERATIVE DIAGNOSIS: PATIENT UNDERWENT RIGHT KNEE REPLACEMENT (B)(6) 2017. PATIENT UNDERWENT A RIGHT REVISION TOTAL KNEE ARTHROPLASTY TO TREAT THE CHRONIC PROSTHETIC INFECTION (B)(6) 2018. ALL COMPONENTS EXCHANGED.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8361900 ↗
• InjuryDec 21, 2018Crack; Fracture; Crack; Fracture

  AS REPORTED: "PATIENT PRIMARY PS KNEE WAS REVISED DUE TO PS POST BREAKAGE FROM IMPLANT. PREVIOUS (BROKEN) #7 11MM PS INSERT WAS REPLACED WITH A NEW #7 11MM PS INSERT". SPOKE TO REP. NO POSSIBLE CAUSE(S) OR CONTRIBUTOR(S) FOR DEVICE FAILURE WERE REPORTED, SURGEON HAD NO THEORY AS TO HOW IMPLANT BREAKAGE OCCURRED..

  Patient problems: Injury

  MAUDE report 8190328 ↗
• InjuryAug 9, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S RIGHT KNEE WAS REVISED DUE TO INFECTION (UNKNOWN IF CLINICALLY CONFIRMED OR IDENTIFIED). A 7X11 PS INSERT WAS SWAPPED FOR A 7X9 PS INSERT.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7769183 ↗
• InjurySep 12, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT UNDERWENT I&D WASHOUT WITH ONLY EXCHANGE OF LINER ON (B)(6) 2017.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 6859076 ↗