Triathlon 5537-G-411-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327287691), received between Jan 8, 2020 and Nov 13, 2024 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 18, 2026.

Recalls naming this device

1. Feb 6, 2024Class IIOpen, Classified

   Potential packaging breaches of inner blister and outer sterile blister.

   Z-1264-2024 · Root cause: Packaging · Recall details · FDA record ↗

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.

• InjuryNov 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY SALES REP : REVISION DUE TO INFECTION, CHANGE OF INSERT.

  Patient problems: Unspecified Infection

  MAUDE report 20672847 ↗
• InjuryMar 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 WOUND DRAINAGE. AS REPORTED BY REP: "DR OPTED TO PERFORM AN EXTENSIVE I&D AND LINER EXCHANGE, NO COMPLAINTS FILED AGAINST THE COMPONENTS THEMSELVES."

  Patient problems: Fluid Discharge

  MAUDE report 16458078 ↗
• InjuryMar 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "ABOUT 3-4 WEEKS POST REIMPLANTATION SURGERY, THE SUBJECT CONTINUED TO HAVE DRAINAGE FROM HER [LEFT] KNEE. REPEAT ASPIRATION WAS STILL POSITIVE FOR INFECTION. AT THIS TIME THE INFECTION HAS BECOME CHRONIC AND THE PATIENT WAS INDICATED FOR AN EXPLANT AND PLACEMENT OF A STATIC ANTIBIOTIC SPACER. FINDINGS: GROSS INTRAOPERATIVE PURULENCE WITH INFLAMED SYNOVIUM WELL FIXED FEMORAL AND TIBIAL AND PATELLAR COMPONENTS."

  Patient problems: Unspecified Infection

  MAUDE report 13767235 ↗
• MalfunctionDec 20, 2021Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  AS REPORTED: "DURING SURGERY, THE WIRE OF THE TS POLY IMPLANT WAS PARTIALLY EXPOSED AND NOT FULLY SEATED EVEN BEFORE IMPLANTATION. PLEASE SEE THE ATTACHED PICTURE." PER MPS: OCCURRED DURING A MAKO KNEE. THE WIRE WAS PROTRUDING, AND WHEN THE SURGEON TRIED TO SEAT IT THE WIRE CAME OUT. THERE WAS APPROXIMATELY A 5 MINUTE SURGICAL DELAY WITH A TOURNIQUET IN USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13049300 ↗
• InjuryJan 8, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO PAIN AND ROM ISSUES. SURGEON PERFORMED A DEBRIDEMENT OF SCAR TISSUE AND REVISED A 4X11 TS INSERT FOR ANOTHER 4X11 TS INSERT. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED INSERT, AND REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury; Loss of Range of Motion; Pain

  MAUDE report 9566590 ↗

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-1263-2024 · Feb 6, 2024 · Open, Classified
  NO 3 TRIATHLON TS PLUS TIB INS X3 POLY 11 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-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