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Triathlon 5540-A-502Recalls & reported problems

Howmedica Osteonics Corp. · Femoral Distal 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 07613327015096), received between Jun 16, 2022 and Jun 16, 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

Patient problems

  • Inadequate Osseointegration2
  • Pain2

Recent adverse event reports

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

  • InjuryJun 16, 2022Loss of Osseointegration; Loss of Osseointegration

    IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED. AS REPORTED BY REP: "PT. PRESENTED WITH THIGH PAIN, IMAGING WAS INDICATIVE OF A LOOSE FEMORAL IMPLANT FOLLOWING A KNEE-REVISION "BACK IN (B)(6) OF 2017". SURGEON RULED OUT INFECTION AND DETERMINED THE FEMORAL CONSTRUCT WAS ASEPTICALLY LOOSE. HE PERFORMED A REVISION OF THE FEMORAL IMPLANTS, LEAVING THE TIBIAL BASEPLATE AND STEM IN-SITU. NO FURTHER INFORMATION AVAILABLE." SPOKE TO REP. NO WEAR OR DAMAGE WAS NOTED INTRA-OPERATIVELY.

    Patient problems: Inadequate Osseointegration; Pain

    MAUDE report 14723112 ↗
  • InjuryJun 16, 2022Loss of Osseointegration; Loss of Osseointegration

    IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED. AS REPORTED BY REP: "PT. PRESENTED WITH THIGH PAIN, IMAGING WAS INDICATIVE OF A LOOSE FEMORAL IMPLANT FOLLOWING A KNEE-REVISION "BACK IN (B)(6) OF 2017". SURGEON RULED OUT INFECTION AND DETERMINED THE FEMORAL CONSTRUCT WAS ASEPTICALLY LOOSE. HE PERFORMED A REVISION OF THE FEMORAL IMPLANTS, LEAVING THE TIBIAL BASEPLATE AND STEM IN-SITU. NO FURTHER INFORMATION AVAILABLE." SPOKE TO REP. NO WEAR OR DAMAGE WAS NOTED INTRA-OPERATIVELY.

    Patient problems: Inadequate Osseointegration; Pain

    MAUDE report 14723095 ↗

Other PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER devices

All PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER devices →

Sources and updates

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