Triathlon 5537-G-511-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327288315), received between Nov 13, 2020 and Jun 4, 2024 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN MUA WAS PERFORMED ON THE PATIENT'S LEFT KNEE ON (B)(6) 2023. PRE-MUA ROM 5-85 DEGREES; POST MUA 0-125 DEGREES.

  Patient problems: Loss of Range of Motion

  MAUDE report 19459180 ↗
• InjuryMar 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "WASH OUT PERFORMED ON THE LEFT KNEE FOR ONGOING FUNGAL INFECTION. A 5X11 TS INSERT WAS EXCHANGED FOR A 5X13 TS INSERT.

  Patient problems: Fungal Infection

  MAUDE report 13824674 ↗
• InjuryNov 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PT. PRESENTED WITH A DRAINING SURGICAL-WOUND. TS+ INSERT WAS SWAPPED OUT AS PART OF DR¿S I & D PROTOCOL. NO COMPLAINTS HAVE BEEN MADE AGAINST THE IMPLANTS THEMSELVES." SPOKE TO REP, WHO PROVIDED THE REVISION USAGE SHEET. A 5X11 TS INSERT WAS EXCHANGED FOR ANOTHER OF THE SAME CATALOG NUMBER.

  Patient problems: Unspecified Infection

  MAUDE report 12819549 ↗
• MalfunctionNov 13, 2020Device-Device Incompatibility; Device-Device Incompatibility

  PROCEDURE: REVISION KNEE FOR INFECTION. I&D OF KNEE WITH TS INSERT REMOVAL AND EXCHANGE FOR NEW TS INSERT. IMPACTING NEW 5X11 TS INSERT WENT FINE UNTIL INSERTING THE METAL REINFORCEMENT POST CAUSED INSERT TO RISE UP UNLOCKING THE WIRE. HAD TO CUT AROUND POLY POST TO REMOVE THE METAL POST AND THEN INSERT A 2ND NEW INSERT. ON THE SECOND NEW INSERT IMPACTION WAS VERIFIED TO BE SEATED FLUSH AND LOCKED AND AGAIN INSERTING THE METAL POST CAUSED THE INSERT TO LIFT UP IN THE FRONT CAUSING A GAP BETWEEN THE BASEPLATE AND THE INSERT. IMPACTING THE INSERT FURTHER DID NOT CAUSE THE INSERT TO SET FLUSH AS IT SHOULD. A THIRD TS 5X11 INSERT WAS THEN IMPLANTED AND SUCCESSFULLY LOCKED. THE SURGEON COMMENTED THE METAL POST BARBS DID ENGAGE IN THE PLASTIC BUT DIDN'T WANT TO CONTINUE IMPACTING FOR CONCERN THAT THE INSERT WOULD LIFT UP AGAIN. SURGICAL DELAY: YES.

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

  MAUDE report 10837503 ↗
• MalfunctionNov 13, 2020Device-Device Incompatibility; Device-Device Incompatibility

  PROCEDURE: REVISION KNEE FOR INFECTION. I&D OF KNEE WITH TS INSERT REMOVAL AND EXCHANGE FOR NEW TS INSERT. IMPACTING NEW 5X11 TS INSERT WENT FINE UNTIL INSERTING THE METAL REINFORCEMENT POST CAUSED INSERT TO RISE UP UNLOCKING THE WIRE. HAD TO CUT AROUND POLY POST TO REMOVE THE METAL POST AND THEN INSERT A 2ND NEW INSERT. ON THE SECOND NEW INSERT IMPACTION WAS VERIFIED TO BE SEATED FLUSH AND LOCKED AND AGAIN INSERTING THE METAL POST CAUSED THE INSERT TO LIFT UP IN THE FRONT CAUSING A GAP BETWEEN THE BASEPLATE AND THE INSERT. IMPACTING THE INSERT FURTHER DID NOT CAUSE THE INSERT TO SET FLUSH AS IT SHOULD. A THIRD TS 5X11 INSERT WAS THEN IMPLANTED AND SUCCESSFULLY LOCKED. THE SURGEON COMMENTED THE METAL POST BARBS DID ENGAGE IN THE PLASTIC BUT DIDN'T WANT TO CONTINUE IMPACTING FOR CONCERN THAT THE INSERT WOULD LIFT UP AGAIN. SURGICAL DELAY: YES.

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

  MAUDE report 10837501 ↗

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-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-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-1261-2024 · Feb 6, 2024 · Open, Classified
  X3 TRIATHLON CS INSERT NO 6 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