Triathlon 5530-G-511Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07613327050547), received between Mar 21, 2017 and Sep 15, 2025 — classified as 8 injuries, 3 malfunctions.

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

• InjurySep 15, 2025Unstable; Unstable

  NO NEW INFORMATION.

  Patient problems: Joint Laxity; Loss of Range of Motion; Pain

  MAUDE report 23059384 ↗
• InjuryAug 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "RIGHT REVISION TOTAL KNEE ARTHROPLASTY. DIAGNOSIS: PAIN DUE TO INTERNAL ORTHOPEDIC PROSTHETIC DEVICES. NO FURTHER INFORMATION AVAILABLE PER HOSPITAL." A 5X11 CR INSERT WAS REVISED TO A 5X14 CS INSERT.

  Patient problems: Pain

  MAUDE report 15328126 ↗
• InjuryNov 17, 2021Material Erosion; Fracture; Unstable; Material Erosion; Fracture; Unstable

  KNEE REVISION DUE TO INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 12832255 ↗
• InjuryJun 15, 2021Unstable; Unstable

  REVISION OF INSERT DUE TO INSTABILITY.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 11998334 ↗
• InjuryOct 28, 2019Fracture; Fracture

  PRIMARY OF LEFT KNEE. PATIENT HAD NO PAIN BUT X-RAYS SHOWED A FRACTURED POLYETHENE INSERT. THERE WAS METAL DEBRIS INSIDE THE PATIENT BUT THERE WAS NO DAMAGE TO THE PATIENT THAT WAS EXAMINED THROUGH VISUAL EXAMINATION. NO ADDITIONAL INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury

  MAUDE report 9246423 ↗
• InjuryFeb 28, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INFECTION. A 5X11 CR INSERT WAS EXCHANGED FOR A 5X9 CR INSERT.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8380144 ↗
• InjuryDec 11, 2018Naturally Worn; Naturally Worn

  A REVISION KNEE PROCEDURE WAS REQUIRED FOLLOWING A TRIATHLON CR PRIMARY KNEE IMPLANTED IN (B)(6) 2008. WHEN THE REVISION TOOK PLACE THE X3 POLY INSERT WAS SEEN TO HAVE DELAMINATED ON THE MEDIAL SIDE AND SHOWED SIGNS OF WEAR ON POSTERIOR LATERAL SIDE AS WELL.

  Patient problems: Injury

  MAUDE report 8150865 ↗
• MalfunctionOct 17, 2018Unintended Movement; Unintended Movement

  UPON INSERTION OF TRIATHLON CR 5X11 INSERT, THE PLASTIC WOULD NOT SEAT FULLY. NUMEROUS ATTEMPTS WERE MADE. SURGEON NOTED THAT WIRE WAS EXPOSED BUT THAT INSERT SEEMED FULLY SEATED. A NEW INSERT WAS OPENED AND IMPLANTED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7975554 ↗
• MalfunctionJul 25, 2018Mechanical Problem; Mechanical Problem

  DURING A TRIATHLON TOTAL KNEE PROCEDURE, AFTER IMPLANTATION ON THE FINAL PROSTHESIS, THE POLY THICKNESS NEEDED TO BE INCREASED. THE INITIAL POLY WAS REMOVED AND ANOTHER INSERTED. THE POLY WAS UNABLE TO BE LOCKED INTO THE BASE PLATE AND WAS DOWN LATERALLY BUT RAISED MEDIALLY. AFTER SEVERAL ATTEMPTS TO SEAT THE POLY IT HAD TO BE REMOVED AND ANOTHER IMPLANTED. THIS TIME SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7718685 ↗
• InjuryJun 28, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  A 5 BY 11MM X3 WAS REMOVED DURING A REVISION SURGERY. SURGERY WAS PERFORMED DUE TO LACK OF MOTION.

  Patient problems: Ambulation or Postural Difficulties; Injury

  MAUDE report 6673117 ↗
• MalfunctionMar 21, 2017Material Distortion; Material Distortion

  IT WAS REPORTED THAT THE LINER EXCHANGE WAS "WARPED". IT WAS REPORTED THAT THE LINER WOULD NOT MATE, AND THAT A SECOND LINER WAS OPENED AND USED SUCCESSFULLY. IT WAS REPORTED THAT THE "WARPED" LINER WAS DISPOSED OF AT THE HOSPITAL. IT WAS REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES AND SURGICAL DELAY WAS LESS THEN FIVE MINUTES WHILE A NEW LINER WAS OPENED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6423079 ↗