Triathlon 5532-G-516Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327050806), received between Apr 24, 2018 and Oct 21, 2021 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryOct 21, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO DISLOCATION OF THE FEMORAL COMPONENT OFF OF THE BACK OF THE INSERT. THE INSERT WAS REVISED. REP REPORTED THAT HE CAN PROVIDE USAGE, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Dislocation

  MAUDE report 12673558 ↗
• InjuryJul 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SURGICAL SITE INFECTION, RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 12189432 ↗
• InjuryAug 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  REVISION SURGERY: CHRONIC GONALGIA IN OUTCOME OF ARTHROSURFACE CFM PATIENT UNDERWENT THE FIRST LEFT KNEE ARTHROPLASTY IMPLANT DUE TO A GONARTHROSIS.

  Patient problems: Injury; Pain

  MAUDE report 8920708 ↗
• InjuryMar 14, 2019Osseointegration Problem; Insufficient Device Problem Information; Osseointegration Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "DEGENERATIVE ARTHRITIS, RIGHT KNEE".

  Patient problems: Injury; Osteolysis

  MAUDE report 8421210 ↗
• InjuryApr 24, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S RIGHT KNEE WAS REVISED DUE TO INFECTION (INFECTION REPORTED BY SURGEON, MICROORGANISM NOT IDENTIFIED). AN I&D WAS PERFORMED AND THE POLY WAS EXCHANGED.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7456739 ↗