Triathlon 5530-G-509Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 07613327050530), received between Sep 28, 2017 and Sep 30, 2025 — classified as 19 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (9 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO NEW INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 23180057 ↗
• InjuryDec 14, 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 DUE TO INFECTION (REPORTED AS E. COLI). ALL COMPONENTS WERE REMOVED AND A FEMORAL COMPONENT WITH ALL-POLY TIBIA WERE IMPLANTED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 18326973 ↗
• InjuryAug 30, 2021Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO INSTABILITY. A 5X9 CR INSERT WAS REVISED TO A 5X11 CS INSERT.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 12384511 ↗
• InjuryJul 12, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED FOR CHRONIC PAIN. A 5X9 POLY WAS EXCHANGED FOR A NEW ONE. SPOKE TO REP: REVISION AND PRIMARY USAGE SHEET'S WERE PROVIDED BUT OTHERWISE NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Pain

  MAUDE report 12148667 ↗
• InjuryJun 15, 2021Unstable; Unstable

  REVISION OF INSERT DUE TO INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 12002685 ↗
• InjuryMay 7, 2021Unstable; Unstable

  CHANGE OF POLY LINER FROM 9MM TO THICKER. PATIENT HAD KNEE LAXITY, PAIN AND INSTABILITY.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 11789421 ↗
• InjuryFeb 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "(LEFT KNEE) REVISED FOR PAIN AND LIMITED RANGE OF MOTION. NO ALLEGATIONS AGAINST THE IMPLANTS. NO FURTHER INFORMATION AVAILABLE DUE TO HOSPITAL POLICY." A FEMORAL COMPONENT, INSERT, AND TIBIAL BASEPLATE WERE REVISED.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 11269401 ↗
• InjuryNov 15, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO FAILED LEFT KNEE ARTHROPLASTY.

  Patient problems: Insufficient Information

  MAUDE report 10841557 ↗
• InjuryOct 19, 2020Adverse Event Without Identified Device or Use Problem; Noise, Audible; Adverse Event Without Identified Device or Use Problem; Noise, Audible

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED. AS REPORTED BY REP: "PAIN AND CLICKING IN KNEE." A 5X9 CR INSERT WAS REVISED TO A 5X9 CS INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Pain

  MAUDE report 10699519 ↗
• InjuryFeb 19, 2020Unstable; Malposition of Device; Unstable; Malposition of Device

  POLY REVISION CASE FOR INSTABILITY OF THE POLY. WEAR ON POLY. SURGEON ASKED IF THE POLY COULD BE SENT FOR REVIEW.

  Patient problems: Injury; Joint Laxity

  MAUDE report 9728243 ↗
• InjuryMay 22, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "STATUS POST LEFT TKR WITH PROSTHETIC JOINT IMPLANT FAILURE".

  Patient problems: Injury; Insufficient Information

  MAUDE report 8632953 ↗
• InjuryMay 8, 2019Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED AFTER "PATIENT COMPLAINS OF PAIN, SWELLING, AND NOISE IN KNEE". AN OFFICE VISIT FROM (B)(6) 2019 STATES "...I THINK THE MORE LIKELY EXPLANATION IS DEFORMATION OR BREAKAGE OF ONE OR MORE OF THE PLASTIC COMPONENTS IN THE LEFT KNEE...". A 5X9 CR INSERT AND METAL-BACKED PATELLA WERE REVISED. REP PROVIDED AN OPERATIVE REPORT, PATIENT VITALS, PRE-REVISION X-RAYS, IMPLANT RECORDS, AND EXPLANT PICTURES AND REPORTED THAT NO FURTHER INFORMATION.

  Patient problems: Injury; Pain; Swelling

  MAUDE report 8592657 ↗
• InjuryApr 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED. AS REPORTED BY REP: "REMOVED FEMORAL COMPONENT, TIBIAL BASEPLATE, TIBIAL INSERT, AND PATELLA [FEMORAL COMPONENT, BASEPLATE, AND PATELLA IMPLANTED (B)(6) 2018. LINER WAS IMPLANTED/ REVISED (B)(6) 2019]. WASHED OUT THE CAVITY AND IMPLANTED AN ANTIBIOTIC CEMENT SPACER¿NO OTHER INFORMATION IS AVAILABLE". REP CONFIRMED REASON FOR REVISION WAS POSSIBLE INFECTION.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8527931 ↗
• InjuryApr 17, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  REVISION OF LEFT KNEE DUE TO POPPING AND PAINFUL SENSATION. ORIGINAL SURGERY WAS (B)(6) 2010. PICTURES OF EXPLANTED IMPLANTS WERE PROVIDED. NO FURTHER INFORMATION WILL BE PROVIDED BY THE HOSPITAL OR SURGEON.

  Patient problems: Injury; Pain

  MAUDE report 8525139 ↗
• InjuryNov 12, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED, PATIENT HAD LEFT KNEE REVISION. UPDATE (B)(4) 2018: REVISION DUE TO POSSIBLE INFECTION. A CR INSERT WAS EXCHANGED FOR A 5 X 9 CR INSERT.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8059791 ↗
• InjuryOct 25, 2018Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT PATIENT'S RIGHT KNEE WAS REVISED DUE TO PAIN.

  Patient problems: Injury; Pain

  MAUDE report 8006241 ↗
• InjuryAug 20, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S LEFT KNEE WAS REVISED. AS REPORTED BY REP: "PAIN AND CLICKING IN ANTERIOR KNEE". AN A35 PATELLA AND 5/9 CR INSERT WERE REVISED TO AN A38 X3 PATELLA AND 5/11 CR INSERT.

  Patient problems: Injury; Pain

  MAUDE report 7797874 ↗
• InjuryJun 25, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT REPORTED THAT SHE HAD BILATERAL TKA, RIGHT KNEE WAS DONE ON (B)(6) 2009 AND LEFT KNEE (B)(6) 2009. PATIENT STARTED TO EXPERIENCE PAIN IN 2012.

  Patient problems: Pain

  MAUDE report 7634880 ↗
• InjurySep 28, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT SURGEON PERFORMED A REVISION OF PATIENT'S LEFT KNEE DUE TO INFECTION (CLINICALLY CONFIRMED, TYPE/ SEVERITY/ ONSET UNKNOWN). PROCEDURE CONSISTED OF AN IRRIGATION & DEBRIDEMENT WITH A POLY EXCHANGE.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 6903116 ↗