Triathlon 5530-G-613Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327050608), received between Oct 2, 2018 and Nov 30, 2021 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 30, 2021Break; Degraded; Break; Degraded

  IT WAS REPORTED THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO WEAR AND BREAKAGE OF THE INSERT. THE INSERT WAS REVISED. THE SURGEON HAS REQUESTED THE PART BE RETURNED AND THAT HE BE PROVIDED INVESTIGATION RESULTS.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 12904971 ↗
• InjuryJan 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED. A 6 X 13 CR INSERT WAS EXCHANGED FOR THE SAME CATALOG NUMBER. REP REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED. UPDATE: REP HAS INDICATED REVISION DUE TO INFECTION.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8260623 ↗
• InjuryOct 2, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION IMPLANT SHEET THAT PATIENT'S LEFT KNEE WAS REVISED. A 6X13 CR INSERT WAS REVISED TO A 6X16 CR INSERT. UPDATE: PATIENT WAS REVISED DUE TO INFECTION.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7927388 ↗