Skip to content

Triathlon 5549-A-120Recalls & reported problems

Howmedica Osteonics Corp. · Tritanium Tibial Symmetric Cone Augment · Class 2 · Implant

All models of Triathlon (608)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327000610), received between Nov 15, 2019 and May 26, 2022 — classified as 2 injuries.

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

Device problems

  • Loss of Osseointegration2
  • Insufficient Device Problem Information1

Patient problems

  • Inadequate Osseointegration2
  • Bone Fracture(s)1
  • Injury1
  • Pain1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryMay 26, 2022Loss of Osseointegration; Loss of Osseointegration

    PATIENT HAD A LEFT KNEE SURGERY WHERE STRYKER COMPONENTS WERE IMPLANTED ON (B)(6) 2019. PATIENT WAS REVISED ON (B)(6) 2020 FOR LOOSENING.

    Patient problems: Inadequate Osseointegration; Pain

    MAUDE report 14506312 ↗
  • InjuryNov 15, 2019Loss of Osseointegration; Insufficient Device Problem Information; Loss of Osseointegration; Insufficient Device Problem Information

    MEDICAL RECORDS PROVIDED FOR LEGAL PI 2144066 HAVE INDICATED ADDITIONAL TREATMENTS/REVISIONS THE PATIENT UNDERWENT. THIS PI IS FOR A THIRD REVISION SURGERY THE PATIENT UNDERWENT ON (B)(6) 2018 DUE TO LOOSENING ON TIBIAL SIDE (BASEPLATE/TIBIAL STEM/AUGMENT) LOOSENING. AN INTRAOPERATIVE FRACTURE OF THE TIBIA WAS ALSO REPORTED TO HAVE OCCURRED DURING THIS REVISION SURGERY ON (B)(6) 2019. EXCERPT FROM MEDICAL REVIEW: "EARLY LOOSENING OF BASEPLATE WITH STEM EXTENDER AND AUGMENT OCCURRED REQUIRING A THIRD REVISION SURGERY." "REMOVING ALL BONE CEMENT FROM THE TIBIAL CANAL WAS AGAIN DIFFICULT AND REQUIRED MAKING A WINDOW IN THE TIBIAL CORTICAL BONE FOR DISTAL ACCESS TO THE BONE CEMENT FOR REMOVAL. LATERAL AND POSTERIOR ¿CRACKS¿ DEVELOPED IN THE TIBIAL CORTEX DURING THESE DIFFICULT MANOEUVRES TO REMOVE ALL BONE CEMENT."

    Patient problems: Bone Fracture(s); Inadequate Osseointegration; Injury

    MAUDE report 9328913 ↗

Other PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices

All PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page