Triathlon 5532-G-611Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 07613327050851), received between Feb 3, 2017 and Apr 6, 2026 — classified as 21 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (11 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryApr 6, 2026Fracture

  THE FOLLOWING INFORMATION WAS PROVIDED: PATIENT WAS BROUGHT TO OR WITH SLIGHT INSTABILITY AND HAD CLUNKING IN THE KNEE. AT REVISION ARTHROPLASTY, IT WAS DISCOVERED THE POST ON A PS POLY IMPLANT HAD BROKEN OFF AT THE BASE.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity

  MAUDE report 24791426 ↗
• InjuryMay 15, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO A BROKEN POST ON A TRIATHLON PS INSERT. SURGEON REPORTED THAT THE PATIENT'S WEIGHT WAS A CONTRIBUTING FACTOR. A 6X11 PS INSERT WAS REPLACED WITH ANOTHER 6X11 PS INSERT. REP PROVIDED PICTURES AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 22025935 ↗
• InjuryAug 22, 2024Degraded; Fracture; Degraded; Fracture

  PATIENT WAS REVISED DUE TO UNSTABLE KNEE; POLY WAS COMPROMISED WHEN KNEE OPENED AND POLY WAS REPLACED SUCCESSFULLY. POLY NEEDED TO BE SWAPPED OUT DUE TO WEAR. ADDITIONAL INFO. 08-AUG-2024: ¿ COULD YOU PLEASE PROVIDE DETAILS AS TO WHAT IS MEANT BY ¿POLY WAS COMPROMISED¿? - PATIENT WAS REVISED DUE TO FEMUR MOVING ANTERIOR ON TIBIA IN FLEXION, WHEN OPENED UP SAW THAT THE POLY POST WAS BROKEN AND THUS ALLOWING FEMUR TO MOVE FORWARD, OLD POLY WAS REMOVED AND SAME THICKNESS POLY WAS INSERTED SUCCESSFULLY. WE DO NOT KNOW WHAT ALLOWED THE POST TO DISSOCIATE LIKE THAT. ¿ LEFT OR RIGHT SIDE: LEFT SIDE.

  Patient problems: Joint Laxity

  MAUDE report 20039066 ↗
• InjuryApr 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SEPTIC MOBILIZATION OF RIGHT KNEE PROSTHESIS. IMPLANTATION DATE: 2018.

  Patient problems: Unspecified Infection

  MAUDE report 19104473 ↗
• InjuryOct 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INFECTION. A POLY SWAP WAS PERFORMED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 17983377 ↗
• InjuryNov 15, 2022Adverse 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 POSSIBLE INFECTION. AN I&D WAS PERFORMED AND A 6X11 PS INSERT WAS REVISED TO A 6X12 PS INSERT. REP PROVIDED PRIMARY AND REVISION USAGE AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 15797362 ↗
• InjuryApr 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOW-UP OF TRIATHLON TRITANIUM OUTCOMES STUDY, PATIENT REPORTED DISSATISFACTION WITH THEIR KNEE REPLACEMENT. ADDITIONAL COMMENTS: "TO GET THROUGH THE DAY I HAVE TO WEAR AN ACE KNEE SUPPORT. I THOUGHT I WOULD HAVE BETTER USE OF MY KNEE AND COULD DO MORE WITHOUT PAIN. I HAVE PAIN DAILY. I HAVE TO WEAR AN ELASTIC KNEE BRACE DAILY AND HAVEN'T PLAYED GOLF IN 2 1/2 YEARS!"

  Patient problems: Pain

  MAUDE report 14187048 ↗
• InjuryMar 11, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INFECTION. A 6X11 PS INSERT WAS SWAPPED FOR ANOTHER 6X11 PS INSERT. REVISION TOOK PLACE AT AN UNKNOWN FACILITY BY AN UNKNOWN SURGEON. REP REPORTED NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9819955 ↗
• InjuryMar 11, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A STAGE 1 REVISION WAS PERFORMED ON THE PATIENT'S RIGHT KNEE DUE TO INFECTION. THE PATIENT'S KNEE CONSTRUCT WAS REMOVED AND A SPACER WAS PLACED. REP REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9819529 ↗
• InjuryDec 23, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  RIGHT KNEE. POSSIBLE INFECTION PS POLY EXCHANGE RIGHT KNEE FROM ORIGINAL IMPLANT DATE OF (B)(6) 2019.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9512586 ↗
• InjuryJul 25, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: Injury; Scar Tissue

  MAUDE report 8827610 ↗
• InjuryApr 26, 2019Noise, Audible; Noise, Audible

  THIS PI IS FOR CLICKING NOISE AND PAIN AFTER REVISION. AS PER OP REPORT, PATIENT IS EXPERIENCING PAIN AND CLICKING NOISE 2 WEEKS POST REVISION.

  Patient problems: Injury; Pain

  MAUDE report 8556845 ↗
• InjuryApr 1, 2019Break; Degraded; Break; Degraded

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED AFTER PATIENT PRESENTED WITH A COMPLAINT IN (B)(6) 2018 (NATURE OF THE COMPLAINT NOT REPORTED TO REP). INTRA- OPERATIVELY, THE TIP OF THE DEVICE WAS BROKEN OFF AND ONE SIDE WAS WORN.

  Patient problems: Injury

  MAUDE report 8471880 ↗
• InjuryMar 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INFECTION. INFECTION WAS CLINICALLY CONFIRMED BUT INFECTING MICROORGANISM WAS NOT IDENTIFIED. IT WAS REPORTED TO THE REP THAT THE PATIENT HAD AN INFECTION WHICH BEGAN IN THE HEART, MIGRATED TO PATIENT'S NATIVE HIP, THEN MIGRATED TO BOTH OF PATIENT'S TOTAL KNEE CONSTRUCTS (LEFT KNEE CONSTRUCT WAS A COMPETITOR CONSTRUCT). SURGEON SWAPPED OUT A 6X11 PS INSERT FOR A 6X11 CR INSERT.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8444534 ↗
• InjuryFeb 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  POSTOPERATIVE DIAGNOSIS: PATIENT UNDERWENT LEFT KNEE REPLACEMENT (B)(6) 2016. PATIENT UNDERWENT A RIGHT REVISION TOTAL KNEE ARTHROPLASTY (B)(6) 2017 WITHOUT EVIDENCE OF INFECTION DUE TO PAIN AND DISCOMFORT. ONE COMPONENT LINER EXCHANGED.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8362011 ↗
• InjuryNov 29, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S RIGHT KNEE WAS REVISED DUE TO PAIN (POSSIBLE CAUSES OF OR CONTRIBUTORS TO PAIN NOT REPORTED TO REP). A 6 X 11 PS INSERT AND A35 10MM PATELLA WERE REVISED TO A 6X13 TS INSERT AND ANOTHER A35 10MM PATELLA.

  Patient problems: Injury; Pain

  MAUDE report 8117723 ↗
• InjuryOct 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT LOST RANGE OF MOTION AND UNDERWENT REVISION OF LINER FROM AN 11MM TO A 9MM. ALL OTHER COMPONENTS WERE RETAINED ON (B)(6) 2018".

  Patient problems: Ambulation or Postural Difficulties; Injury; Loss of Range of Motion

  MAUDE report 7969504 ↗
• InjuryOct 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  "PROCEDURE: PATIENT UNDERWENT RIGHT TOTAL KNEE REPLACEMENT (B)(6) 2017. PATIENT RETURNED FOR PAIN AND DISABILITY. PATIENT UNDERWENT REVISION ON (B)(6) 2018 FOR SUSPICION OF FEMORAL COMPONENT LOOSENING (BASED ON A BONE SCAN), AT SURGERY ALL COMPONENTS WERE FOUND TO BE WELL FIXED. ONLY POLY WAS EXCHANGED."

  Patient problems: Disability; Injury; Pain

  MAUDE report 7968835 ↗
• InjuryJun 12, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S LEFT KNEE WAS REVISED DUE TO INFECTION (INFECTION REPORTED BY SURGEON, UNKNOWN IF CLINICALLY IDENTIFIED, REP REPORTED KNEE WAS "FULL OF PUS"). ALL PRIMARY IMPLANTS WERE REMOVED AND REPLACED WITH A CEMENT SPACER.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7592155 ↗
• InjuryJan 9, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  EVENT: TOTAL KNEE WAS LOOSE WITH AN 11MM THICK INSERT. SURGEON REMOVED INSERT AND IMPLANTED A 16MM INSERT. PATIENT IS STABLE.

  Patient problems: Injury

  MAUDE report 7174940 ↗
• InjuryFeb 3, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT IS STATUS POST OP TOTAL KNEE REPLACEMENT (B)(6) 2016. PATIENT WAS SUSPECTED FOR INFECTION. HE WAS BROUGHT THE OR FOR A WASHOUT AND POLY EXCHANGE. NO APPARENT SIGNS OF INFECTION. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Injury

  MAUDE report 6301729 ↗