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Triathlon 5537-G-311Recalls & reported problems

Howmedica Osteonics Corp. · Total Stabilizer+ Tibial Insert · Class 2 · Implant

All models of Triathlon (608)

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

Adverse event reports
3
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327027136), received between Sep 28, 2020 and Dec 2, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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

  • Insufficient Device Problem Information2
  • Fracture1

Patient problems

  • Insufficient Information2
  • Ambulation or Postural Difficulties1
  • Bacterial Infection1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjuryDec 2, 2022Fracture; Fracture

    IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO THE POST OF THE TS INSERT SHEARING OFF (INCLUDING THE METAL POST). A 3X11 TS INSERT WAS REVISED TO A 3X16 TS INSERT.

    Patient problems: Ambulation or Postural Difficulties; Insufficient Information

    MAUDE report 15903676 ↗
  • InjuryOct 16, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INFECTION. ALL IMPLANTS (ALL EXCEPT LINER IMPLANTED (B)(6) 2016, LINER IMPLANTED (B)(6) 2020 WERE REVISED AND A STATIC SPACER PLACED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

    Patient problems: Bacterial Infection

    MAUDE report 10689537 ↗
  • InjurySep 28, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

    THIS PI IS FOR THE REVISION OF THE PATIENT'S RIGHT KNEE ON (B)(6) 2020. IN REPORTING A REVISION OF THE PATIENT'S RIGHT KNEE ON (B)(6) 2020, THE REP PROVIDED A REVISION IMPLANT SHEET FROM (B)(6) 2020 FOR A POLY SWAP WHICH WAS PERFORMED DUE TO INFECTION. A 3X11 TS INSERT WAS EXCHANGED FOR ANOTHER 3X11 TS INSERT.

    Patient problems: Insufficient Information

    MAUDE report 10592845 ↗

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

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