Triathlon 5532-G-616Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327050875), received between Jun 4, 2018 and Apr 25, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 25, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  FOLLOW-UP OF TRIATHLON TRITANIUM OUTCOMES STUDY, PATIENT REPORTED DISSATISFACTION WITH THEIR KNEE REPLACEMENT. ADDITIONAL COMMENTS: "EXTREME."

  Patient problems: Insufficient Information

  MAUDE report 14191587 ↗
• InjuryJul 25, 2019Unstable; Unstable

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

  Patient problems: Injury; Pain

  MAUDE report 8827735 ↗
• InjurySep 21, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  REV OF TOTAL KNEE FOR INSTABILITY. AS REPORTED IN "HOW WAS ISSUE NOTICED": PATIENT COMPLAINT.

  Patient problems: Injury

  MAUDE report 7897734 ↗
• InjuryJun 4, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT PRESENTED WITH LAXITY IN RIGHT KNEE. TKA WAS PREVIOUSLY PERFORMED ON (B)(6) 2015. DECISION WAS MADE TO UP SIZE TIBIAL INSERT FROM 16 MM TO A 19 MM PS INSERT.

  Patient problems: Injury

  MAUDE report 7567138 ↗