Triathlon 5532-P-511Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327042801), received between Mar 22, 2018 and Jan 7, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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 16, 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.

• InjuryJan 7, 2025Unstable; Unstable

  AS REPORTED: "PATIENT IS STATUS POST REVISION LEFT TKA DUE TO GLOBAL INSTABILITY. NO ADDITIONAL DETAILS PROVIDED BY THE FACILITY." A 5X11 PS INSERT WAS REVISED TO A 5X16 TS INSERT.

  Patient problems: Joint Laxity

  MAUDE report 21095555 ↗
• InjuryAug 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT IS STATUS POST REV LTKA DUE TO INFECTION. ORIGINAL DATE OF SURGERY WAS (B)(6) 2019. PATIENT IS S/P POLY SWAP COMPLETED ON (B)(6) 2023 (PI (B)(6)). NO ADDITIONAL DETAILS PROVIDED BY THE FACILITY.

  Patient problems: Unspecified Infection

  MAUDE report 20011675 ↗
• MalfunctionMar 22, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT UPON OPENING THE PRODUCT PACKAGING, IT APPEARED THE INSERT WAS CONTAMINATED.

  Patient problems: No Patient Involvement

  MAUDE report 7363268 ↗