Triathlon 5532-G-709-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07613327338010), received between Mar 5, 2020 and May 27, 2026 — classified as 12 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INFECTION. A 7X9 PS INSERT WAS EXCHANGED FOR A 7X11 PS INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 25305026 ↗
• InjuryApr 1, 2025Adverse 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. PATIENT FELL 1 DAY POST-OP AND REOPENED THE SURGICAL WOUND. A WASHOUT AND POLY EXCHANGE OF A 7X9 PS INSERT WAS PERFORMED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Fall

  MAUDE report 21748960 ↗
• MalfunctionDec 4, 2024Difficult to Insert; Detachment of Device or Device Component; Difficult to Insert; Detachment of Device or Device Component

  REPORTED EVENT: IN TRIATHLON PS TKR SURGERY, THE TRIATHLON X3 TIBIAL BEARING INSERT- PS INSERT WAS TO BE IMPLANTED. ON FINAL IMPLANTING, THE INSERT DIDN'T LOCK IN THE TIBIA AND THE PIN SEEN ON ANTERIOR SIDE OF INSERT WAS PREVENTING FULL LOCKING. THE INSERT WAS TAKEN OUT AND NO LONGER USABLE. THERE WAS ANOTHER TRIATHLON PS INSERT FOR BACK UP SO THAT WAS USED AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20842636 ↗
• InjurySep 10, 2024Unstable; Unstable

  LEFT KNEE. PATIENT. PRESENTED WITH SOME INSTABILITY. DR. OPTED TO DO A "LINER SWAP." NO COMPLAINTS FILED AGAINST THE COMPONENTS THEMSELVES, NO FURTHER INFO AVAILABLE.

  Patient problems: Joint Laxity

  MAUDE report 20182548 ↗
• InjuryJun 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ANSM REPORTED THAT: "FOLLOWING SURGERY FOR TOTAL PROSTHESIS OF THE RIGHT KNEE, AN INFECTION APPEARED AFTER REMOVAL OF THE STAPLES AROUND AROUND 04/25/2024, AND A RED SPOT APPEARED WHICH SUPPURATED AT THE LEVEL OF THE SCAR. SINCE THEN, THE SURGEON WAS INFORMED OF THIS AND SAW ME AGAIN TO PERFORM AN OPERATION TO OPEN, REMOVE AND WASH THE WOUND, AS WELL AS CHANGE THE CLIP-ON PART. AND TO CHANGE THE CLIP-ON PART OF THE PROSTHESIS. THIS OPERATION TOOK PLACE ON (B)(6) 2024, AFTER WHICH I WAS PLACED UNDER MONITORING AT THE CLINIC AND UNDER TREATMENT EVER SINCE. TO DATE, ON 05/14/2024, I'M STILL ON ANTIBIOTICS, WHICH HAVE BEEN REINFORCED SINCE 05/11/2024, BUT I STILL HAVE A FEVER. SAMPLES HAVE REVEALED THE PRESENCE OF BACILLI AND STAPHYLOCOCCI IN MY ORGANISM, AND I'M STILL WAITING FOR THE RESULTS OF THE 3 SAMPLES PATIENT'S CURRENT CONDITION: MY GENERAL CONDITION: WEIGHT LOSS (ABOUT 8 KG), SEVERE FATIGUE DUE TO LACK OF SLEEP, NUTRITIONAL DEFICIENCIES. I AM REQUESTING TRANSFER TO A HOSPITAL SPECIALIZING IN INFECTIOUS DISEASES RELATED TO THE FITTING OF PROSTHESES. PROSTHESES. ACTIONS TAKEN IN THE CARE FACILITY TO MANAGE THE PATIENT: NR".

  Patient problems: Unspecified Infection

  MAUDE report 19498050 ↗
• InjuryJul 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  WHILE COVERING A REVISION OF THE PATIENT'S RIGHT KNEE, REP WAS TOLD THE PATIENT HAD A PRIOR REVISION DUE TO A RUPTURED TENDON. SURGEON PERFORMED A TENDON REPAIR AND EXCHANGED THE INSERT. THIS REPORT IS FOR RUPTURED TENDON REVISION.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 15039701 ↗
• InjuryDec 17, 2021Adverse 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. SURGEON SWAPPED A 7X9 PS INSERT FOR ANOTHER OF THE SAME TYPE AND SIZE. PRIMARY WAS DONE APPROXIMATELY 2 YEARS AGO. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 13029361 ↗
• InjuryAug 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "...RIGHT KNEE REVISION DUE TO PATELLAR TENDON RUPTURE. NO MORE INFORMATION IS AVAILABLE PER DOCTOR." SPOKE TO REP. THERE ARE NO ALLEGATIONS AGAINST THE REVISED INSERT WITH RESPECT TO THE PATELLAR TENDON RUPTURE. A 7X9 PS INSERT WAS EXCHANGED FOR ANOTHER 7X9 PS INSERT. REP PROVIDED THE PRIMARY USAGE SHEET.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 12384646 ↗
• InjuryAug 24, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INFECTION. A SIZE 7 FEMORAL COMPONENT, UNIVERSAL TIBIAL BASEPLATE, AND 7X9 PS INSERT WERE REMOVED AND A SPACER PLACED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 12363687 ↗
• InjuryAug 10, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INFECTION. A POLY EXCHANGE WITH INCISION AND DRAINAGE WAS PERFORMED. REP PROVIDED THE REVISION USAGE SHEET AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 12304636 ↗
• InjuryFeb 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A STAGE 1 REVISION ON A RIGHT MAKO KNEE IMPLANTED (B)(6) 2020 WAS PERFORMED DUE TO A STAPH INFECTION. ALL COMPONENTS WERE REMOVED AND IMPLANTS USED AS A SPACER WERE PLACED. REP PROVIDED PRIMARY AND REVISION USAGE AND A PICTURE OF THE EXPLANTS, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 11364546 ↗
• InjuryJan 4, 2021Adverse 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. AN IRRIGATION AND DEBRIDEMENT WITH WASHOUT AND POLY SWAP WAS PERFORMED.

  Patient problems: Unspecified Infection

  MAUDE report 11113687 ↗
• InjuryMar 5, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INFECTION. REP PROVIDED USAGE SHEETS FROM PRIMARY, PRIOR REVISION, AND THE STAGE 1 REVISION PERFORMED NOW. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9794620 ↗

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-1265-2024 · Feb 6, 2024 · Open, Classified
  NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM
• Z-1266-2024 · Feb 6, 2024 · Open, Classified
  NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 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-1263-2024 · Feb 6, 2024 · Open, Classified
  NO 3 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