Triathlon 5532-G-316Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327050677), received between Feb 25, 2020 and Nov 9, 2021 — classified as 2 injuries, 1 malfunction.

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

• MalfunctionNov 9, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  TRIATHLON WAS USED FOR A PATIENT IN TKR SURGERY. WHILE THE INSERT WAS LOCKED SURGEON FOUND THE COCR WIRE MISSING IN THE INSERT AND FOUND ON THE TABLE DETACHED FROM THE INSERT.- THE SURGERY WAS DELAYED BY HALF AN HOUR, THE TIME TAKEN TO PROVIDE SAME SIZE INSERT, FROM OFFICE TO HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12779305 ↗
• InjuryJun 24, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE SUBMISSION OF PRIMARY AND REVISION USAGE SHEETS THAT THE PATIENT'S RIGHT KNEE WAS REVISED. A 3 X 16 PS INSERT (5532-G-316) WAS REVISED TO ANOTHER 3 X 16 PS INSERT (5532-G-316-E).

  Patient problems: Injury

  MAUDE report 10189484 ↗
• InjuryFeb 25, 2020Unstable; Unstable

  DR. REVISED A PS INSERT FROM A 3X16 TO A 3X19 DUE TO PATIENT STIFFNESS/INSTABILITY. HE REMOVED MANY BONE SPURS. ORIGINAL SURGERY WAS (B)(6) 2012.

  Patient problems: Injury

  MAUDE report 9750455 ↗