Triathlon 5532-G-809Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327046342), received between Aug 24, 2018 and May 23, 2023 — classified as 5 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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.

• InjuryMay 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENTS LEFT KNEE WAS REVISED. ALL COMPONENTS WERE REMOVED AND CONVERTED TO A TS KNEE.

  Patient problems: Insufficient Information

  MAUDE report 16982525 ↗
• InjuryDec 2, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED. AFTER GETTING A FLU SHOT, PATIENT FELT UNWELL AND AN ACHE DEVELOPED IN HIS KNEE SHORTLY AFTER. INFECTION WAS CONFIRMED AND A POLY SWAP WITH WASHOUT WAS PERFORMED. REP PROVIDED THE PRIMARY USAGE SHEET AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 10934079 ↗
• InjuryMar 12, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "RIGHT KNEE POLY EXCHANGE DUE TO SUPERFICIAL INFECTION. CASE DONE ON (B)(6) 2020. NO MORE INFORMATION IS AVAILABLE PER DOCTOR." REP PROVIDED THE PRIMARY USAGE SHEET AND INDICATED THAT THE INSERT WAS REVISED.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9822892 ↗
• InjuryAug 28, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INFECTION (INFECTION REPORTED BY SURGEON. UNKNOWN IF CLINICALLY CONFIRMED, INFECTING MICROORGANISM UNKNOWN). AN IRRIGATION & DEBRIDEMENT WAS PERFORMED WITH AN EXCHANGE OF THE 8X9 PS INSERT FOR ANOTHER 8X9 PS INSERT PLUS ANTIBIOTIC BEADS. REP REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8942310 ↗
• InjuryAug 24, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A SYNOVECTOMY AND LINER EXCHANGED WERE PERFORMED ON PATIENT'S LEFT KNEE. REP REPORTED THAT PATIENT HAS A HISTORY OF PVNS (PIGMENTED VILLONODULAR SYNOVITIS, A JOINT DISEASE CHARACTERIZED BY INFLAMMATION AND OVERGROWTH OF THE JOINT LINING).

  Patient problems: Inflammation; Injury

  MAUDE report 7814187 ↗