Triathlon 5537-G-219Recalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327027075), received between Oct 18, 2017 and Aug 15, 2024 — classified as 4 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.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information2
- Degraded1
- Unstable1
Patient problems
- Injury3
- Pain1
- Unspecified Infection1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryAug 15, 2024Degraded; Degraded
IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO PAIN. THE PATIENT'S TS KNEE WAS CONVERTED TO A PS KNEE. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Pain
MAUDE report 19997441 ↗InjuryJun 23, 2020Unstable; Unstable
A REVISION IMPLANT SHEET WAS SUBMITTED FOR PATIENT'S LEFT KNEE. REP NOTES ON THE SHEET STATE: "A SIZE 2 19MM (TS INSERT) WAS REMOVED. A SIZE 2 16MM (TS INSERT) WAS IMPLANTED. REASON: PATELLA RUPTURE. NO FURTHER INFORMATION WILL BE GIVEN DUE TO HOSPITAL POLICY."
Patient problems: Injury
MAUDE report 10183142 ↗InjuryOct 30, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT A STAGE 1 REVISION WAS PERFORMED ON THE PATIENT'S RIGHT KNEE DUE TO INFECTION. ALL COMPONENTS WERE REMOVED AND A STATIC SPACER WAS PLACED. REP PROVIDED THE PRIMARY USAGE SHEET AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.
Patient problems: Injury; Unspecified Infection
MAUDE report 9258104 ↗InjuryOct 18, 2017Insufficient Device Problem Information; Insufficient Device Problem Information
Other PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices
- ATTUNE 1506-00-005Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER589 reports
- ATTUNE 1506-00-004Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER580 reports
- JOURNEY 74012812Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER502 reports
- JOURNEY 74011856Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER438 reports
- PERSONA™ 42-5099-094-00Zimmer, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER406 reports
- JOURNEY 74011857Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER388 reports
- ATTUNE 1506-00-007Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER288 reports
- ATTUNE 1506-00-003Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER271 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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