Triathlon 5565-S-019Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327026832), received between Jul 25, 2019 and Sep 24, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Mechanical Problem” (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.

• InjurySep 24, 2019Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO PROGRESSIVE RADIOLUCENCY AROUND THE TIBIAL AND FEMORAL STEMS. A KNEE CONSTRUCT WITH TIBIAL BASEPLATE AND STEM, FEMORAL COMPONENT AND STEM, AND A CS INSERT WERE REVISED TO A TS CONSTRUCT. REP PROVIDED A WEBOPS REPORT, AN EXCERPT FROM AN OPERATIVE REPORT, EXPLANT PICTURES AND X-RAYS FROM (B)(6) 2019 AND REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 9109428 ↗
• InjuryJul 25, 2019Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Mechanical Problem; Adverse Event Without Identified Device or Use Problem

  POSTOPERATIVE DIAGNOSIS: THE PATIENT HAD A HISTORY OF LEFT KNEE REPLACEMENT (OUTSIDE OF CORS SCOPE). PATIENT UNDERWENT KNEE REVISION FOR MECHANICAL PROBLEM (B)(6) 2017. THE PATELLA WAS RETAINED. THE PATIENT UNDERWENT LEFT KNEE REPLACEMENT REVISION OF FEMORAL COMPONENTS AND POLYETHYLENE (B)(6) 2019.

  Patient problems: Injury; Joint Laxity

  MAUDE report 8825981 ↗