Triathlon 5537-G-309Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327027129), received between Jun 25, 2018 and Aug 9, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Component Missing” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 9, 2019Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO FAILED LEFT TOTAL KNEE ARTHROPLASTY.

  Patient problems: Injury

  MAUDE report 8878689 ↗
• MalfunctionJun 25, 2018Component Missing; Component Missing

  AS REPORTED: "PRODUCT PACKAGE DID NOT INCLUDE LOCKING PEG. SIZE 11MM, SIZE 3 TS INSERT WAS USED INSTEAD. NO UNUSUAL CIRCUMSTANCES OTHER THAN NO PEG IN PACKAGE".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7635280 ↗