Triathlon 5532-G-109Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327046137), received between Aug 26, 2020 and Apr 12, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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.

• InjuryApr 12, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO PATELLA PAIN. WHEN THE SURGEON RESECTED SOME BONE FROM THE PATELLA, IT LOOSENED THE JOINT SO A THICKER POLY WAS USED. OTHERWISE, THERE ARE NO ALLEGATIONS AGAINST THE REVISED POLY. THE PATIENT WAS REVISED FROM A 1X9 PS POLY TO A 1X14 PS POLY. REP CONFIRMED THAT NO FURTHER INFORMATION WOULD BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Pain

  MAUDE report 11653108 ↗
• MalfunctionAug 26, 2020Device-Device Incompatibility; Device-Device Incompatibility

  THE SALES REP WAS IN A CASE WITH THE SURGEON. THE SURGEON INSERTED THE BASE PLATE FINE AND WENT TO INSERT A 1 X 9MM PS INSERT. HOWEVER, THIS DID NOT FIT AS HE WOULD LIKE AND HE DECIDED TO EXTRACT IT. THE SALES REP ADVISED THAT EXTRACTING THE INSERT WOULD CAUSE IT TO BREAK (IT DID, THE LOCKING WIRE BROKE) AND THERE WAS NOT A SPARE 1 X 9MM PS INSERT TO HAND. THE SURGEON PROCEEDED TO USE A 1 X 11MM INSERT TO COMPLETE THE CASE. HE WAS HAPPY WITH THE RESULT. THE CORRECT SIZE DID NOT SIT A PLANNED ON THE BASE PLATE. UPDATE: SURGICAL DELAY 5-10MINS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10453557 ↗