Triathlon 5532-G-309-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07613327337945), received between Jan 28, 2022 and Dec 11, 2025 — classified as 10 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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.

• InjuryDec 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: THE PATIENT HAD AN INDEX LEFT TKA ON (B)(6) 2023. THE PATIENT DEVELOPED PJI AND WAS REVISED ON (B)(6) 2024. ONLY THE POLY WAS EXCHANGED.

  Patient problems: Unspecified Infection

  MAUDE report 23783699 ↗
• InjuryAug 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PT. REPORTED; IN REGARD TO A RECALL THAT YOU CURRENTLY HAVE AND I JUST RECENTLY FOUND OUT I'VE BEEN HAVING A LOT OF ISSUES WITH MY KNEE I HAD DOUBLE KNEE REPLACEMENT BUT THE NUMBER THAT'S ON MY KNEE THAT I'M LOOKING AT THE SURGICAL PAPERWORK IS LOG: 423-8566. ADDITIONAL INFO. 7/29/2025: PT STATED THEY HAVE BEEN EXPERIENCING PAIN & SWELLING SINCE THEY HAD THEIR RIGHT KNEE PROCEDURE ON (B)(6) 2021 WHICH HAS MADE IT DIFFICULT TO WALK.

  Patient problems: Ambulation or Postural Difficulties; Pain; Swelling/ Edema

  MAUDE report 22813994 ↗
• MalfunctionJul 24, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  WHEN IMPLANT (INSERT) IS OPENED AND INSERTED, MEDIAL IS FULLY FIXED BUT LATERAL SIDE WASN'T FIXED BECAUSE WIRE WAS CAUGHT IN THE MIDDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22586156 ↗
• InjuryNov 15, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO FIBROSIS AND LIMITED ROM. A 3X9 PS INSERT WAS REVISED TO A 3X9 INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Fibrosis; Loss of Range of Motion

  MAUDE report 20693292 ↗
• InjuryOct 8, 2024Unstable; Unstable

  TKA POLY-SWAP. PT. PRESENTED WITH SOME INSTABILITY OF THE RIGHT-KNEE FOLLOWING A FALL "SOME TIME AGO." DR. OPTED TO SWAP FROM A PS-INSERT TO A TS-INSERT. NO FURTHER INFO AVAILABLE.

  Patient problems: Joint Laxity

  MAUDE report 20395573 ↗
• MalfunctionMay 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IN TRIATHLON PS TKR SURGERY, THE TRIATHLON X3 TIBIAL BEARING INSERT- PS INSERT WAS TO BE IMPLANED. THE STAINLESS STEEL WIRE USUALLY VISIBLE ON THE ANTERIOR/ FRONT SIDE OF THE TRAITHLON X3 PS INSERT WAS ABSENT AND WAS IN LOOSE FORM & WAS JUST PACKED ALONG WITH THE INSERT. THE INSERT WAS NO LONGER USABLE. THERE WAS ANOTHER TRAITHLON 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 19330283 ↗
• InjuryMar 22, 2024Malposition of Device; Unintended Movement; Malposition of Device; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED BECAUSE THE KNEE WAS IN VARUS. A TRIATHLON PS KNEE WAS REVISED TO A TRIATHLON TS KNEE WITH STEMS AND AUGMENTS. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 18957854 ↗
• MalfunctionJan 22, 2024Device Damaged Prior to Use; Detachment of Device or Device Component; Device Damaged Prior to Use; Detachment of Device or Device Component

  DURING TRIATHLON PS TKR SURGERY, TRIATHLON X3 TIBIAL BEARING INSERT- PS INSERT WAS TO BE IMPLANTED. THE STAINLESS STEEL WIRE PLACED ON THE ANTERIOR/ FRONT SIDE OF THE TRIATHLON X3 PS INSERT CAME OUT WHILE IMPLANTING AND THE INSERT WAS 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 18550557 ↗
• InjuryJul 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 POOR ROM. A DEBRIDEMENT AND POLY EXCHANGE WAS PERFORMED.

  Patient problems: Loss of Range of Motion

  MAUDE report 17359539 ↗
• InjuryDec 20, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED: PATIENT HAD A MANIPULATION UNDER ANESTHESIA.

  Patient problems: Insufficient Information

  MAUDE report 16014658 ↗
• InjuryNov 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT LEFT VOICEMAIL ON PATIENT HOTLINE REPORTING A PRIMARY IMPLANT ON (B)(6) 2020 WITH TRIATHLON COMPONENTS. PATIENT REPORTED "MULTIPLE PROBLEMS SINCE" AND WOULD LIKE TO KNOW IF IMPLANTS ARE SUBJECT TO A RECALL. UPDATE: PER CONVERSATION WITH PATIENT: PATIENT REPORTS PAIN AND SWELLING AND NOTED FEMORAL NERVE DAMAGE DURING PRIMARY SURGERY.

  Patient problems: Nerve Damage; Pain; Swelling/ Edema

  MAUDE report 15825840 ↗
• InjuryOct 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED A VAS PAIN SCORE OF 6 AT 34 DAYS POSTOPERATIVELY. THE PATIENT ALSO SUBMITTED INCISION PHOTOS OUT TO 32 DAYS POSTOPERATIVELY. AFTER REVIEW OF THE PATIENT-REPORTED DATA IN ORTHOLOGIQ, INCLUDING A HIGHER-THAN-EXPECTED VAS PAIN SCORE, PERSISTENTLY LIMITED RANGE OF MOTION AND PRESENCE OF A WOUND VACUUM (AT DAY 32 POST-OP), THE CARE TEAM BROUGHT THIS PATIENT INTO OFFICE FOR EXAMINATION AND SUSPECTED ACUTE INFECTION. A POSTOPERATIVE TIBIAL LINER EXCHANGE WAS PERFORMED FOR THE ACUTE INFECTION.

  Patient problems: Loss of Range of Motion; Pain; Unspecified Infection

  MAUDE report 15573749 ↗
• InjuryJan 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A STAGE 1 REVISION WAS PERFORMED ON THE PATIENT'S RIGHT KNEE DUE TO INFECTION. ALL IMPLANTS WERE REMOVED AND A SPACER WAS PLACED.

  Patient problems: Unspecified Infection

  MAUDE report 13382256 ↗

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-1263-2024 · Feb 6, 2024 · Open, Classified
  NO 3 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
• Z-1264-2024 · Feb 6, 2024 · Open, Classified
  NO 4 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-1265-2024 · 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-1266-2024 · Feb 6, 2024 · Open, Classified
  NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 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