Triathlon 5537-G-419Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327027259), received between Feb 21, 2019 and Dec 11, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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.

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.

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

  THE FOLLOWING INFORMATION WAS PROVIDED: REVISED A LEFT KNEE DUE TO INFECTION. SURGEON REVISED THE TIBIAL INSERT AND DID AN I&D.

  Patient problems: Unspecified Infection

  MAUDE report 23783702 ↗
• InjuryJul 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED A "WASHOUT" ON HER RIGHT KNEE DUE TO INFECTION. PATIENT NOTED NOTHING WAS REMOVED. UPDATE: DURING THIS PROCEDURE WHICH OCCURRED ON (B)(6) 2021, THE INSERT WAS REVISED IN ADDITION TO THE REPORTED IRRIGATION AND DEBRIDEMENT. DISCHARGE NOTES FURTHER INDICATE THAT OXACILLIN-SENSITIVE STAPHYLOCOCCUS LUGDUNENSIS GREW FROM AN ASPIRATED FLUED CULTURE THAT WAS TAKEN PRIOR TO THIS PROCEDURE.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 17332200 ↗
• InjuryMar 14, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "REVISION LEFT TOTAL KNEE ARTHROPLASTY, ONE COMPONENT ONLY. FINDINGS: MULTIDIRECTIONAL INSTABILITY, ANTERIORLY MEDIALLY AND LATERALLY; POSTERIORLY STABILIZED."

  Patient problems: Ambulation or Postural Difficulties; Injury

  MAUDE report 8421166 ↗
• InjuryFeb 27, 2019Device Dislodged or Dislocated; Noise, Audible; Device Dislodged or Dislocated; Noise, Audible

  AS REPORTED: "SURGEON SAW THIS PATIENT SIX WEEKS POST OP AND FOUND OUT BY X-RAY THAT THE PATIENT'S POLY HAD DISASSOCIATED FROM THE TIBIAL TRAY. THE PATIENT MENTIONED THAT THEY HEARD A POP WHEN WALKING AND NOTICED A NOISE WHEN GOING THROUGH RANGE OF MOTION. DURING REVISION SURGERY, THE INSERT WAS [FOUND TO BE] DISASSOCIATED FROM THE TRAY AND STICKING HALFWAY OUT ANTERIORLY".

  Patient problems: Injury

  MAUDE report 8374920 ↗
• InjuryFeb 21, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  POSTOPERATIVE DIAGNOSIS: PATIENT HAD RIGHT KNEE REPLACEMENT OUTSIDE OF CORS SCOPE. THE PATIENT UNDERWENT KNEE REVISION TO TREAT THE PAIN AND DYSFUNCTION AND MECHANICAL PROBLEM ON (B)(6) 2013. THEN PATIENT HAD INFECTED PROSTHESIS RIGHT KNEE AND ONLY THE POLY COMPONENT WAS EXCHANGED ON (B)(6) 2013.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8358829 ↗