Triathlon 5531-G-611-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 07613327337341), received between Jun 15, 2020 and Feb 10, 2026 — classified as 15 injuries.

The most frequently reported specific device problem is “Unstable” (4 reports).

1 FDA recall record name this device's identifier, 1 still open.

6 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.

Recalls naming this device

1. Feb 6, 2024Open, Classified

   Potential packaging breaches of inner blister and outer sterile blister.

   Z-1261-2024 · Root cause: Packaging · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: THE REVISION TODAY OF A LEFT TOTAL KNEE WAS SECONDARY TO INFECTION. ALL ORIGINAL IMPLANTS WERE REMOVED, THE JOINT WAS WASHED OUT, AND NEW IMPLANTS WERE PLACED. THE USE OF MAKO IN THE INDEX SURGERY WAS NOT THOUGHT TO HAVE CONTRIBUTED TO THIS COMPLICATION.

  Patient problems: Unspecified Infection

  MAUDE report 24303032 ↗
• InjuryOct 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RIGHT TOTAL KNEE. THE REVISION TODAY WAS SECONDARY TO INFECTION. 6X11 CS INSERT WAS EXCHANGED FOR ANOTHER. THE USE OF MAKO IN THE INDEX SURGERY WAS NOT THOUGHT TO HAVE CONTRIBUTED TO THIS COMPLICATION. NO FURTHER INFORMATION IS AVAILABLE FROM THE DOCTOR OR HOSPITAL.

  Patient problems: Unspecified Infection

  MAUDE report 20356151 ↗
• InjuryMay 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 6X11 CS INSERT WAS EXCHANGED FOR ANOTHER OF THE SAME CATALOG NUMBER. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 19234312 ↗
• InjuryApr 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "REVISION RTKA WITH ARTICULATING SPACER PLACEMENT BECAUSE OF INFECTION." REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 19114346 ↗
• InjuryApr 8, 2024Adverse 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. A FIRST OF A TWO STAGE REVISION WAS PERFORMED ON (B)(6) 2024 WITH PLACEMENT OF A SPACER. THE 2ND STAGE REMOVAL OF THE SPACER AND PLACEMENT OF PERMANENT IMPLANTS WAS PERFORMED ON (B)(6) 2024.

  Patient problems: Unspecified Infection

  MAUDE report 19059009 ↗
• InjuryMar 16, 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. A 6X11 CS INSERT WAS EXCHANGED FOR ANOTHER 6X11 CS INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 16551053 ↗
• InjuryJan 20, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT'S KNEE WAS REVISED. APPROXIMATELY 1 MONTH POST-IMPLANT, X-RAYS SHOWED THAT THE INSERT WAS NOT LOCKED INTO THE BASEPLATE. A 6X11 CS INSERT WAS REVISED TO A 6X10 CS INSERT. REP CAN PROVIDE SOME ADDITIONAL INFORMATION (REFER TO COMMUNICATIONS LOG), AND CONFIRMED THAT OTHERWISE, NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 16213512 ↗
• InjuryDec 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED KNEE INFECTION AFTER PRIMARY. PATIENT NOTED THAT INFECTION WAS TREATED BY A DENTIST WITH AN ANTIBIOTIC. PATIENT WOULD LIKE TO KNOW IF IMPLANTS ARE SUBJECT TO RECALL. UPDATE PER PATIENT RESPONSE: "I HAVE NO COMPLAINTS, JUST TRYING TO MAKE SURE ALL PARTS ARE GOOD TO GO SO I CAN REQUEST THE EXACT SAME MODEL FOR THE LEFT KNEE AND HAVE A SUCCESSFUL, QUICK RECOVERY."

  Patient problems: Unspecified Infection

  MAUDE report 16018180 ↗
• InjurySep 9, 2022Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INSTABILITY (REP CONFIRMED THAT NOTHING WAS REPORTED WORN, BROKEN, OR LOOSE). A 6X11 CS INSERT WAS REVISED TO A 6X14 CS INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity

  MAUDE report 15394002 ↗
• InjuryJun 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A STAGE 1 REVISION WAS PERFORMED ON THE PATIENT'S RIGHT KNEE DUE TO INFECTION. ALL IMPLANTS WERE REMOVED AND A SPACER WAS PLACED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 14839374 ↗
• InjuryMar 13, 2022Unstable; Unstable

  AS REPORTED: "PT. PRESENTED WITH MID-FLEXION INSTABILITY. OPTED TO REVISE THE FEMUR COMPONENT AND INSERT OPTION, LEAVING THE TIBIAL-BASEPLATE COMPONENT IN-SITU." RIGHT KNEE. A CR FEMORAL COMPONENT AND CS INSERT WERE REVISED TO A TS FEMORAL COMPONENT WITH STEM, EXTENDER, AND AUGMENTS, AND A TS INSERT. REP PROVIDED REVISION USAGE SHEET. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity

  MAUDE report 13752424 ↗
• InjuryFeb 18, 2021Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO LIGAMENT INSTABILITY. THE FEMORAL COMPONENT AND INSERT WERE REVISED. REP REPORTED HE CAN POSSIBLY PROVIDE PRIMARY AND REVISION USAGE, AND CONFIRMED THAT OTHERWISE NO FURTHER INFORMATION WOULD BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 11343551 ↗
• InjuryDec 21, 2020Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO INSTABILITY. SURGEON REPORTED THAT THE PATIENT'S FEMORAL COMPONENT DISLOCATED POSTERIORLY FROM THE INSERT. A 6X11 CS INSERT WAS REVISED TO A THICKER CS INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 11044536 ↗
• InjuryOct 22, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED: PATIENT HAS CLEAR LIQUID OOZING FROM WOUND. SURGEON PREFORMED I&D AND POLY SWAP.

  Patient problems: Bacterial Infection

  MAUDE report 10718993 ↗
• InjuryJun 15, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  DR (B)(6) REPORTS PATIENT (B)(6) A STATUS POST PRIMARY LEFT TOTAL KNEE DONE ON (B)(6)2020 APPEARS INFECTED AND REQUESTS TO REMOVE THE IMPLANTS AND PUT IN AN ANTIBIOTIC SPACER. DR (B)(6) CAREFULLY REMOVED THE IMPLANTS USING FLEXIBLE OSTEOTOMES AND A SAW. HE THEN PROCEEDED TO DEBRIDE AND WASH THE BONE. ONCE REMOVED AND WASHED HE IMPLANTED AN ANTIBIOTIC SPACER MADE OF CEMENT LADEN WITH EXTRA ANTIBIOTICS. THE PROCEDURE WAS PERFORMED WITHOUT INCIDENT. NO FURTHER INFORMATION IS AVAILABLE. CORRECTION 01/JUNE/2020 WG: BRANCH PROVIDED IMPLANT SHEETS FOR THE ROBOTIC PRIMARY ON (B)(6) 2019 AND A POLY SWAP PERFORMED ON (B)(6) 2020.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 10152143 ↗

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-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-1262-2024 · Feb 6, 2024 · Open, Classified
  X3 TRIATHLON CS INSERT NO 7 9 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