Triathlon 5510-F-101Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327040203), received between Mar 19, 2019 and Nov 16, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Malposition of Device” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 16, 2023Use of Device Problem; Use of Device Problem

  DURING SURGERY FOR BILATERAL TKA, IT WAS DISCOVERED THAT A LEFT FEMORAL COMPONENT WAS USED ON THE RIGHT FEMUR. THE RIGHT SIDE WAS TREATED FIRST, AND THEN MISUSE WAS DISCOVERED DURING THE TREATMENT OF THE LEFT SIDE. THE REVISION SURGERY WITH A FEMORAL COMPONENT FOR THE RIGHT SIDE WAS PERFORMED DURING THE INITIAL SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 18147223 ↗
• InjuryMar 3, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT'S MAKO LEFT KNEE WAS REVISED DUE TO LIMITED RANGE OF MOTION (20° FLEXION, 80° EXTENSION). A SIZE 1 CR FEMUR AND 1X12 CR INSERT WERE REVISED TO A SIZE 1 PS FEMUR AND 1X10 PS INSERT. SURGEON DID NOT REPORT THAT ACCURACY OF BONE CUTS CAUSED OR CONTRIBUTED TO THE ISSUE. REP PROVIDED THE PRIMARY USAGE SHEET AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 13658195 ↗
• InjuryMar 19, 2019Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem

  IT WAS REPORTED THAT PATIENT'S LEFT KNEE WAS REVISED. AS REPORTED BY REP: "...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". UPDATE: A CLINICIAN REVIEW OF THE PROVIDED MEDICAL RECORDS STATES THE FOLLOWING; PROVIDED UNDATED X-RAY CONFIRMS SUBLUXATED FEMORAL COMPONENT POSTERIORLY.

  Patient problems: Injury; Pain; Swelling

  MAUDE report 8433739 ↗