Triathlon 5520-B-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327041040), received between Jun 11, 2018 and Oct 15, 2024 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of Osseointegration” (2 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 15, 2024Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem; Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem

  TRIATHLON WAS IMPLANTED ON (B)(6) 2023 AND THE PATIENT FELL DAY ONE POST OP. PT PRESENTED WITH PAIN (B)(6) 2023, PLAN TO REVISE.

  Patient problems: Fall; Inadequate Osseointegration; Pain

  MAUDE report 20457811 ↗
• InjuryApr 14, 2021Osseointegration Problem; Osseointegration Problem

  RIGHT TKA. REVISION DUE TO LOOSENING OF TIBIAL COMPONENT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11668856 ↗
• InjuryDec 12, 2018Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT PATIENT'S LEFT KNEE WAS REVISED. AS REPORTED: "PROGRESSIVE PAIN, SWELLING, SENSE OF UNRELIABILITY. CT AND X-RAYS REVEALED TIBIAL LOOSENING SOFT TISSUE EFFUSION, CELL COUNT (3,500) AND SYNOVASURE WORRISOME FOR POSSIBLE INFECTION. CULTURES NEGATIVE TO DATE.

  Patient problems: Injury; Pain; Swelling

  MAUDE report 8157900 ↗
• InjuryOct 16, 2018Mechanical Problem; Mechanical Problem

  THE PATIENT UNDERWENT LEFT TOTAL KNEE REPLACEMENT (B)(6) 2018. PATIENT HAD MECHANICAL FAILURE LEFT KNEE ARTHROFIBROSIS AND UNDERWENT LEFT KNEE REVISION ONLY TIBIAL AND PATELLAR COMPONENTS EXCHANGED (B)(6) 2018."

  Patient problems: Injury

  MAUDE report 7971379 ↗
• MalfunctionJun 11, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT, DURING A TKA, WHEN A NURSE OPENED THE BLISTER PACK, A SURGEON FOUND SOME WHITE POWDER ON THE BASE PLATE. A SPARE WAS USED INSTEAD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7587788 ↗