Triathlon 5531-G-409-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 07613327337150), received between Mar 30, 2020 and Aug 26, 2026 — classified as 36 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (7 reports).

7 other recalls cover devices cleared under the same FDA submission (K172634); they may or may not involve this specific model.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• InjuryAug 26, 2026Unstable

  Left knee. Patient had their insert revised due to instability in both flexion and extension. A 4x9 CS insert was exchanged for a 4x11 CS insert. No other information available due to Hospital policy.

  Patient problems: Joint Laxity

  MAUDE report 50461231 ↗
• InjuryMay 5, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: LEFT TOTAL KNEE REPLACEMENT BECAME INFECTED, REPLACED POLY.

  Patient problems: Unspecified Infection

  MAUDE report 25086941 ↗
• InjuryMay 1, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: IN PROVIDING INFORMATION FOR (REVISION OF PATIENT'S RIGHT KNEE ON (B)(6) 2026, REP PROVIDED INFORMATION INDICATING THAT THE PATIENT'S RIGHT KNEE WAS REVISED ON (B)(6) 2025. REASON FOR REVISION IS UNKNOWN. A 4X9 CS INSERT WAS REVISED TO A 4X10 CS INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 25054626 ↗
• InjuryJul 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S KNEE WAS REVISED DUE TO POSSIBLE INFECTION. AN I&D WITH POLY EXCHANGE WAS PERFORMED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 22660005 ↗
• InjuryApr 2, 2025Unstable; Unstable

  IT WAS REPORTED THAT THE SURGEON REVISED A TIBIAL INSERT OF A RIGHT KNEE DUE TO INSTABILITY. HE UPSIZED FROM A 4X9 TO 4X11 CS. NO FURTHER INFORMATION AVAILABLE DUE TO HOSPITAL POLICY.

  Patient problems: Joint Laxity

  MAUDE report 21751034 ↗
• InjuryFeb 5, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO PAIN AND LIMITED ROM. A 4X9 INSERT WAS REVISED TO ANOTHER 4X9 INSERT, AND THE PATIENT'S NATIVE PATELLA WAS RESURFACED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 21315168 ↗
• InjuryDec 10, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  RIGHT TOTAL KNEE. THE REVISION TODAY WAS SECONDARY TO A FALL AND INJURY TO THE PATELLA TENDON. THE 9 MM INSERT WAS REMOVED TO ALLOW FOR WASHING OUT OF THE JOINT AS IT WAS AN OPEN INJURY. A NEW 9MM WAS PLACED AND IT WAS DETERMINED THAT THE JOINT WAS UNSTABLE. AFTER TRIALING A 14MM INSERT WAS IMPLANTED TO STABILIZE THE JOINT. NO FURTHER INFORMATION IS AVAILABLE FROM THE HOSPITAL OR SURGEON.

  Patient problems: Fall

  MAUDE report 20896469 ↗
• MalfunctionSep 12, 2024Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  PRIMARY PROCEDURE, LEFT KNEE. IT WAS REPORTED THAT IMMEDIATELY AFTER REMOVING THE INSERT FROM THE STERILE BLISTER, THE LOCKING WIRE FELL OFF OF THE INSERT. THE INSERT DID NOT COME IN CONTACT WITH THE PATIENT. A SECOND IMPLANT WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY WITH NO DELAY. REP WAS PRESENT FOR AND WITNESS TO THIS EVENT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20199669 ↗
• InjuryApr 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LEFT TOTAL KNEE. THE REVISION TODAY WAS SECONDARY TO PAIN AND ¿CATCHING¿ IN THE POSTERIOR LATERAL PART OF THE KNEE. ON X-RAY A FRAGMENT OF BONE WAS IDENTIFIED AND BELIEVED TO BE CAUSING THE PROBLEM. IN SURGERY THE 9MM INSERT WAS REMOVED TO MAKE ACCESS TO THE BONE FRAGMENT EASIER. THE BONE FRAGMENT WAS REMOVED. AFTER TRIALING SEVERAL INSERTS IT WAS DECIDED THAT AN 11MM INSERT PROVIDED THE BEST STABILITY. THE USE OF MAKO IN THE INDEX PROCEDURE WAS NOT BELIEVED TO HAVE CONTRIBUTED TO THIS PROBLEM. NO FURTHER INFORMATION AVAILABLE FROM THE SURGEON OR HOSPITAL.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 19211377 ↗
• InjuryApr 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A LEFT KNEE REVISION. PATIENT PRESENTED WITH DRAINAGE OF HER LEFT-KNEE FOLLOWING TKA SURGERY ON (B)(6) 2024. DR. PERFORMED AN EXTENSIVE I&D AND INSERT-SWAP, AND DETERMINED THE DRAINAGE RESULTED FROM A SUPERFICIAL ABSCESS. NO COMPLAINTS WERE FILED AGAINST THE COMPONENTS THEMSELVES, NO FURTHER INFO AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 19090630 ↗
• InjuryFeb 7, 2024Material Erosion; Fracture; Unstable; Naturally Worn; Material Erosion; Fracture; Unstable; Naturally Worn

  IT WAS REPORTED: PATIENT CAME BACK DUE TO KNEE PAIN. CASE WENT SMOOTH, ISSUE IS THE POLY HAS WORN OUT ON THE MEDIAL SIDE IN A FEW YEARS. WE ARE REVISING THIS IN TWO WEEKS.

  Patient problems: Joint Laxity; Pain

  MAUDE report 18659692 ↗
• InjuryJan 3, 2024Unstable; Unstable

  REVISED A LEFT TRIATHLON TKA DUE TO INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 18437846 ↗
• InjuryDec 20, 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 SUSPECTED INFECTION. A POLY EXCHANGE WAS PERFORMED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 18369883 ↗
• InjuryDec 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISED A TRIATHLON TIBIAL INSERT OF A RIGHT KNEE DUE TO PATIENT FALLING. HE HAD TO PERFORM A QUAD REPAIR SO IN THAT PROCESS EXPLANTED THE INSERT FOR ACCESS.

  Patient problems: Fall

  MAUDE report 18362401 ↗
• InjuryNov 14, 2023Adverse 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 DUE TO LACK OF MOTION (SURGEON REPORTED CAUSE AS PATIENT DID NOT UNDERGO PHYSICAL THERAPY). A 4X9 CS INSERT WAS EXCHANGED FOR ANOTHER 4X9 CS INSERT, AND SOFT TISSUE DEBRIDEMENT WAS PERFORMED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Loss of Range of Motion

  MAUDE report 18136272 ↗
• InjuryOct 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PERFORMED AN I&D WITH INSERT SWAP OF A LEFT TOTAL KNEE DUE TO POSSIBLE INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 17948668 ↗
• InjuryOct 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EXPLANTED A PRIMARY TRIATHLON LEFT KNEE DUE TO INFECTION. HE PLACED AN ANTIBIOTIC SPACER.

  Patient problems: Unspecified Infection

  MAUDE report 17910724 ↗
• InjuryOct 9, 2023Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S KNEE WAS REVISED DUE TO INSTABILITY. A 4X9 CS INSERT WAS EXCHANGED FOR A 4X13 CS INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity

  MAUDE report 17893045 ↗
• InjurySep 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  I&D ON THE LEFT KNEE OF A PATIENT THAT LAST HAD AN I&D ON (B)(6) 2023 DUE TO INFECTION. DR. INTENDED TODAY TO DO THIS I&D AS A SHORT TERM SOLUTION AND PLANS TO FULLY EXPLANT WITHIN A FEW WEEKS FOR AN ANTIBIOTIC SPACER.

  Patient problems: Unspecified Infection

  MAUDE report 17805595 ↗
• InjuryJun 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DR. PERFORMED AN I&D INSERT SWAP OF A LEFT TKA DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 17234965 ↗
• InjuryJan 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE SALES REP THAT THERE HAS BEEN AN EXCHANGE OF INSERT DUE TO UNKNOWN INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 16190361 ↗
• InjuryDec 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: " RIGHT TOTAL KNEE REPLACEMENT WAS PERFORMED DUE TO STIFFNESS IN THE JOINT."

  Patient problems: Loss of Range of Motion

  MAUDE report 15985682 ↗
• InjuryNov 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RIGHT KNEE MANIPULATION.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 15840913 ↗
• InjuryNov 21, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  LEFT KNEE MANIPULATION ON (B)(6) 2022.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 15832898 ↗
• InjurySep 20, 2022Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  THE FOLLOWING WAS REPORTED: TRIATHLON X3 POLY LOCKING WIRE FAILURE. TKA LEFT.

  Patient problems: Insufficient Information

  MAUDE report 15459647 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K172634. One submission often covers many models, so check the product and lot details in each record.

• Z-1261-2024 · Feb 6, 2024 · Open, Classified
  X3 TRIATHLON CS INSERT NO 6 11 MM
• Z-1263-2024 · Feb 6, 2024 · Open, Classified
  NO 3 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
• Z-1266-2024 · Feb 6, 2024 · Open, Classified
  NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM
• Z-1265-2024 · Feb 6, 2024 · Open, Classified
  NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM
• Z-1264-2024 · Feb 6, 2024 · Open, Classified
  NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
• Z-1262-2024 · Feb 6, 2024 · Open, Classified
  X3 TRIATHLON CS INSERT NO 7 9 MM
• Z-1654-2023 · Apr 13, 2023 · Open, Classified
  TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM Intended for knee replacement Catalog Number: 5532-G-413-E