Triathlon 5531-G-509-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 07613327336511), received between Aug 31, 2020 and Apr 28, 2026 — classified as 42 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Unstable” (5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2026Detachment of Device or Device Component

  THE FOLLOWING INFORMATION WAS PROVIDED: THE LOCKING WIRE FELL OFF EASILY BEFORE IMPACTION.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25019276 ↗
• InjuryDec 17, 2025Unstable; Unstable

  THE FOLLOWING INFORMATION WAS PROVIDED: RIGHT KNEE. PATIENT PRESENTED WITH A CHIEF COMPLAINT OF DISCOMFORT AND MILD INSTABILITY. DR. SWAPPED A 5X9 CS INSERT FOR A 5X11 CS INSERT, AND THE REMAINING COMPONENTS WERE LEFT IN SITU. NO COMPLAINTS AGAINST THE COMPONENTS THEMSELVES, AND NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: Discomfort; Joint Laxity

  MAUDE report 23826296 ↗
• InjuryOct 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE POLY OF A RIGHT MAKO KNEE WAS TAKEN OUT DUE TO INFECTION AND THE HOSPITAL ASKED NO PT DETAILS WERE RELEASED.

  Patient problems: Unspecified Infection

  MAUDE report 23414890 ↗
• InjuryAug 22, 2025Unstable; Unstable

  REVISED A LEFT TRIATHLON TIBIAL INSERT FROM 5X9 TO 5X13 DUE TO PAIN/INSTABILITY.

  Patient problems: Joint Laxity; Pain

  MAUDE report 22871325 ↗
• InjuryJun 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PERFORMED AN I&D WITH INSERT EXCHANGE OF A RIGHT TRIATHLON DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 22174258 ↗
• MalfunctionMay 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PRIMARY PROCEDURE, RIGHT KNEE. IT WAS REPORTED THAT THE LOCKING WIRE FOR THE INSERT WAS LOOSE WHEN IN ITS PACKAGING. WHEN THE INSERT WAS REMOVED, THE WIRE FELL OFF. REP HAD STEPPED OUT OF OR WHEN THE IMPLANT WAS REMOVED FROM ITS PACKAGING, BUT RETURNED TO THE OR RIGHT AFTER, AND WITNESSED THE DISSOCIATED WIRE. A SECOND IMPLANT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22016619 ↗
• InjuryMay 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024, THE STRYKER DEVICES INCLUDING THE INSERT AND THE BASE PLATE WAS IMPLANTED IN THE PATIENT'S LEFT KNEE. BECAUSE OF INFECTION, REVISION SURGERY TO REPLACE THE INSERT WAS PERFORMED ON (B)(6) 2025.

  Patient problems: Unspecified Infection

  MAUDE report 22011336 ↗
• InjuryMar 27, 2025Adverse 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 ROM ISSUES. A DEBRIDEMENT WAS PERFORMED AND A 5X9 CS INSERT WAS SWAPPED FOR ANOTHER 5X9 CS INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Loss of Range of Motion

  MAUDE report 21710794 ↗
• InjuryFeb 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LEFT TOTAL KNEE. THE REVISION TODAY WAS DUE TO STIFFNESS IN THE JOINT. THE PATIENT WAS UNABLE TO EXTEND THE KNEE STRAIGHT AND HAD ALMOST NO FLEXION. IT WAS DECIDED TO DO A HINGE PROSTHESIS DUE TO THE STIFFNESS AND RELEASING REQUIRED TO RESTORE RANGE OF MOTION. THE USE OF MAKO DURING THE INDEX SURGERY WAS NOT THOUGHT TO HAVE CONTRIBUTED TO THIS NEGATIVE OUTCOME. NO FURTHER INFORMATION AVAILABLE FROM THE SURGEON OR HOSPITAL.

  Patient problems: Loss of Range of Motion

  MAUDE report 21342992 ↗
• InjuryJan 28, 2025Adverse 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 JOINT LAXITY. A 5X9 CS INSERT WAS REVISED TO A 5X14 CS INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION IS AVAILABLE FROM THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity

  MAUDE report 21253539 ↗
• InjurySep 6, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED 3 WEEKS POST-OP DUE TO THE INSERT NOT BEING FULLY SEATED INTO THE BASEPLATE. SURGEON REPORTED THAT UPON INITIAL REVIEW OF X-RAY, THE INSERT APPEARED TO BE SEATED, BUT ON REVIEW, THOUGHT THAT IT MAY HAVE BEEN UP SLIGHTLY. INTRA-OPERATIVELY, IT WAS CONFIRMED THAT THE INSERT WAS ONLY PARTIALLY SEATED. A 5X9 CS INSERT WAS EXCHANGED FOR ANOTHER. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 20162745 ↗
• InjuryAug 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PERFORMED AN I&D WITH INSERT EXCHANGE OF A RIGHT TRIATHLON DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 20017455 ↗
• InjuryAug 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PERFORMED AN I&D W INSERT EXCHANGE OF A LEFT TRIATHLON KNEE DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 20001424 ↗
• InjuryJun 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PERFORMED AN I&D AND REVISED A LEFT KNEE TIBIAL INSERT DUE TO POSSIBLE INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 19525457 ↗
• InjuryJan 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: REVISED A TRIATHLON INSERT DUE TO SCAR TISSUE/SOFT TISSUE RELEASE. LEFT KNEE.

  Patient problems: Scar Tissue; Tissue Breakdown

  MAUDE report 18500411 ↗
• InjuryJan 2, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  REVISED A LEFT CEMENTLESS TRIATHLON. HE REVISED THE FEMUR FROM A SZ 5 TO A 4 TS W STEM AND FROM A 5X9 CS TO A 5X9 PS. THIS WAS DUE TO LIMITED RANGE OF MOTION FOR THE PATIENT.

  Patient problems: Loss of Range of Motion

  MAUDE report 18429017 ↗
• InjuryDec 12, 2023Unstable; Noise, Audible; Unstable; Noise, Audible

  IT WAS REPORTED THROUGH THE STRYKER FACEBOOK PAGE, "I HAD MY TKR ON (B)(6) AND I'M STILL IN PAIN, HAVE CLUNKING IN MY KNEE, SWELLING IS STILL PRESENT, I AM DOING OK, WALKING IS FINE, PT IS GOING GOOD I GUESS, ITS DISAPPOINTING TO ME THAT IM THIS LONG INTO IT AND STILL FEEL LIKE I DO? EVERYONE HEALS DIFFERENTLY" ADDITIONAL FB COMMENT, "9 WEEKS IN AND STILL HAVE STIFFNESS AND PAIN, CLICKING WHILE WALKING, I'M REALLY DISAPPOINTED RIGHT NOW, HOPE AND PRAY THINGS START TO GET BETTER, CAN'T STAY OUT OF WORK MUCH LONGER, GETTING FRUSTRATED."

  Patient problems: Joint Laxity; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 18309577 ↗
• InjuryOct 26, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO LIGAMENT LAXITY. THE INSERT WAS REVISED FOR A THICKER INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity

  MAUDE report 18016741 ↗
• InjurySep 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SWAPPED A RIGHT KNEE TRIATHLON INSERT IN ORDER TO RESECT THE PCL, CAPSULE AND SCAR TISSUE OF A KNEE ORIGINALLY DONE ON (B)(6) 2021.

  Patient problems: Posterior Capsule Opacification; Scar Tissue

  MAUDE report 17805596 ↗
• InjuryAug 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DR. PERFORMED A RIGHT KNEE I&D INSERT SWAP ON A TRIATHLON KNEE DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 17627514 ↗
• InjuryJul 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: "REVISED A RIGHT TRIATHLON KNEE DUE TO INFECTION. FULL REVISION TO ALL POLY TIBIA AND PRIMARY CEMENTED."

  Patient problems: Unspecified Infection

  MAUDE report 17377919 ↗
• InjuryJul 18, 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 SUSPECTED INFECTION. A 5X9 CS POLY WAS EXCHANGED FOR ANOTHER 5X9 CS POLY. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 17346784 ↗
• InjuryApr 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A MANIPULATION UNDER ANESTHESIA.

  Patient problems: Insufficient Information

  MAUDE report 16836525 ↗
• InjuryJan 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: SWAPPED POLY DUE TO AN ARTHROTOMY RUPTURE. NO ALLEGATIONS AGAINST THE IMPLANTS.

  Patient problems: Rupture

  MAUDE report 16100468 ↗
• InjuryNov 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "RIGHT KNEE MANIPULATION (B)(6) 2021. RIGHT KNEE ARTHROSCOPY SYNOVECTOMY MANIPULATION ON (B)(6) 2021. EVACUATION OF HEMATOMA AND REMOVAL OF SCAR TISSUE ON (B)(6) 2021. ARTHROTOMY, POLY EXCHANGE, PCL RECESSION AND RELEASE OF POPLITEAL TENDON, EXCISION OF SCAR TISSUE ON (B)(6) 2021." THIS PI IS FOR THE SYNOVECTOMY MANIPULATION ON (B)(6) 2021.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 15834268 ↗

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-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-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-1262-2024 · Feb 6, 2024 · Open, Classified
  X3 TRIATHLON CS INSERT NO 7 9 MM
• Z-1264-2024 · Feb 6, 2024 · Open, Classified
  NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 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