Triathlon 5531-G-609-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 07613327337402), received between Apr 6, 2020 and Aug 6, 2026 — classified as 42 injuries.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50165966 ↗
• InjuryJul 10, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: DR. SAYS HE WOULD LIKE TO REVISE TRIATHLON TKR ON (B)(6) 2026. REASON FOR REVISION UNKNOWN AT THIS POINT.

  Patient problems: Insufficient Information

  MAUDE report 25777353 ↗
• InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem

  REVISED A STRYKER KNEE (LEFT ). THE 6X9 CS INSERT IS BEING REVISED DUE TO INFECTION. HE REPLACED IT WITH ANOTHER 6X 9MM CS POLY. NO VISIBLE SIGNS OF DAMAGE NOR WEAR. NO INTEL ON ORIGINAL IMPLANTATION DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24627645 ↗
• InjuryJan 23, 2026Unstable

  THE FOLLOWING INFORMATION WAS PROVIDED: REVISED A STRYKER POLY (LEFT KNEE) DUE TO INSTABILITY OF THE KNEE. NO VISIBLE SIGNS OF DAMAGE NOR WEAR. A 6X9 CS INSERT WAS REVISED TO A 6X10 CS INSERT. ALSO, DUE TO ANTERIOR KNEE PAIN SO WE ADDED A CEMENTED S29 PATELLA. NO FURTHER INFORMATION TO BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 24159501 ↗
• InjuryNov 13, 2025Degraded; Unstable; Degraded; Unstable

  THE FOLLOWING INFORMATION WAS PROVIDED: AS REPORTED: "I AM WRITING TO DOCUMENT A KNEE REVISION OF THE POLY INSERT DUE TO SLIGHT INSTABILITY AND LEFT KNEE PAIN. NO NOTICEABLE DAMAGE OR WEAR." REP CONFIRMED NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity

  MAUDE report 23542939 ↗
• InjuryJul 28, 2025Unstable; Unstable

  REVISION DUE TO INSTABILITY. THE 9MM INSERT WAS REMOVED AND A 12MM INSERT WAS IMPLANTED TO PROVIDE APPROPRIATE STABILITY. THE USE OF MAKO IN THE INDEX PROCEDURE WAS NOT THOUGHT TO HAVE CONTRIBUTED TO THIS COMPLICATION. NO FURTHER INFORMATION AVAILABLE FROM THE DOCTOR OR HOSPITAL. LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 22635934 ↗
• InjuryJun 30, 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 INFECTION. AND I&D WAS PERFORMED, AND A 6X9 CS INSERT WAS EXCHANGED FOR ANOTHER. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 22357455 ↗
• InjuryJun 4, 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. AN I&D WITH POLY SWAP OF A 6X9 CS INSERT TO A 6X10 CS INSERT WAS PERFORMED, AND CULTURES WERE TAKEN. INFECTION OR SUSPICION OF INFECTION WERE NOT REPORTED TO REP. THE SURGEON IS CONCERNED THAT THE CEMENT USED IN THE PRIMARY PROCEDURE MAY HAVE BEEN FROM THE SAME LOT THAT HAS HAD ISSUES WITH STERILITY INDICATORS, BUT THE LOT CODE OF CEMENT USED IN THIS PROCEDURE IS UNKNOWN. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 22144374 ↗
• InjuryFeb 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "REV RTKA SINGLE STAGE REVISION FOR INFECTION." REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 21432100 ↗
• InjuryFeb 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT ALLEGES ALLERGIC REACTION AND PENDING REVISION FOR BOTH OF HIS KNEE REPLACEMENTS. THIS REPORT IS FOR THE RIGHT KNEE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 21373394 ↗
• InjuryFeb 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT ALLEGES ALLERGIC REACTION AND PENDING REVISION FOR BOTH OF HIS KNEE REPLACEMENTS. THIS PI IS FOR THE LEFT KNEE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 21373391 ↗
• InjurySep 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD THE POLY REVISED DUE TO POSSIBLE INFECTION. NO OTHER INFORMATION AVAILABLE DUE TO HOSPITAL POLICY. LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 20140794 ↗
• InjuryJun 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR PERFORMED THE I&D AND INSERT-SWAP FOR INFECTION ON PATIENT'S LEFT KNEE. NO COMPLAINTS AGAINST THE COMPONENTS THEMSELVES, NO FURTHER INFO AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 19571425 ↗
• InjuryMay 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION USAGE SHEET THAT THE PATIENT'S KNEE WAS REVISED DUE TO INFECTION. A TRIATHLON CS INSERT WAS IMPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 19400414 ↗
• InjuryMay 24, 2024Unstable; Unstable

  DR. (B)(6) REVISED A RIGHT KNEE CS INSERT DUE TO INSTABILITY. HE WENT FROM 6X9 TO 6X12 CS. ORIGINAL SURGERY WAS DONE AT (B)(6) HOSPITAL ON (B)(6) 2020.

  Patient problems: Joint Laxity

  MAUDE report 19389560 ↗
• InjuryApr 2, 2024Adverse 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 INFECTION. A 6X9 CS POLY WAS SWAPPED FOR ANOTHER 6X9 CS POLY.

  Patient problems: Unspecified Infection

  MAUDE report 19017643 ↗
• InjuryApr 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REVISION TODAY WAS SECONDARY TO INFECTION. IT WAS DECIDED TO REMOVE THE FEMUR AND TIBIA IMPLANTS AND LEAVE THE PATELLA IMPLANT. MAKO WAS NOT THOUGHT TO HAVE ANYTHING TO DO WITH THE REVISION. NO FURTHER INFORMATION IS AVAILABLE FROM THE DOCTOR OR HOSPITAL.

  Patient problems: Unspecified Infection

  MAUDE report 19017642 ↗
• InjuryFeb 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A LEFT TKA ON (B)(6) 2023. PATIENT DEVELOPED PERIPROSTHETIC INFECTION AND WAS REVISED ON (B)(6) 2023. ALL COMPONENTS WERE EXCHANGED.

  Patient problems: Unspecified Infection

  MAUDE report 18790256 ↗
• InjuryJan 5, 2024Use of Device Problem; Use of Device Problem

  WAS CONTACTED BY SURGEON ON (B)(6) 2023 ASKING FOR IMPLANT CLARIFICATION FROM A CASE ON (B)(6) 2023. UPON OPENING PDF OF BILL SHEET IT WAS IDENTIFIED THAT A MISMATCHED (SIZE 6) TIBIA CS INSERT, WAS IMPLANTED INTO A (SIZE 7) TRITANIUM TIBIA BASEPLATE AT TIME OF PRIMARY SURGERY. THIS ISSUE WILL RESULT IN AN ADDITIONAL SURGERY FOR A TIBIA INSERT POLY EXCHANGE.

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

  MAUDE report 18449860 ↗
• InjuryNov 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED HE WILL NEED A REVISION DUE TO SWELLING AND STIFFNESS AND WOULD LIKE TO KNOW IF IMPLANTS ARE SUBJECT TO A RECALL.

  Patient problems: Loss of Range of Motion; Swelling/ Edema

  MAUDE report 18214502 ↗
• InjuryNov 1, 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 POSSIBLE INFECTION. AN I&D WITH A POLY SWAP OF A 6X9 CS INSERT WAS PERFORMED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 18045685 ↗
• InjuryJul 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: I&D OF A RIGHT TOTAL KNEE WITH INSERT SWAP DUE TO SUSPECTED INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 17386275 ↗
• InjuryMay 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT CAME IN DUE TO CHRONIC RIGHT KNEE PAIN. GLOBAL THICKENING OF LIGAMENTS, TENDON AND CONNECTIVE TISSUES ASSOCIATED WITH COMPLEX EFFUSION.

  Patient problems: Pain

  MAUDE report 16858512 ↗
• InjuryMay 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED VIA MAKO STRYKER PAGE: "PLEASE HELP. HAD A MAKO TOTAL KNEE 8 MONTHS AGO & UNFORTUNATELY, IT HAS BEEN A FAILURE: SWELLING, STIFFNESS, PAIN GOING DOWN STAIRS & CHALLENGING GOING UPSTAIRS. AM IN NEED OF A 3RD OPINION RECOMMENDATION. SO DISAPPOINTED & DISCOURAGED. HELP & THANK YOU."

  Patient problems: Ambulation or Postural Difficulties; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 16853011 ↗
• InjuryMar 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DR. PERFORMED AN I&D WITH INSERT SWAP DUE TO INFECTION. NO ALLEGATIONS AGAINST THE IMPLANT MADE. RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16492497 ↗

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-1262-2024 · Feb 6, 2024 · Open, Classified
  X3 TRIATHLON CS INSERT NO 7 9 MM
• Z-1265-2024 · Feb 6, 2024 · Open, Classified
  NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM
• Z-1263-2024 · Feb 6, 2024 · Open, Classified
  NO 3 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
• Z-1261-2024 · Feb 6, 2024 · Open, Classified
  X3 TRIATHLON CS INSERT NO 6 11 MM
• Z-1266-2024 · 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-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