Triathlon 5537-G-711Recalls & 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 07613327027464), received between Sep 22, 2018 and May 27, 2026 — 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.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information2
- Adverse Event Without Identified Device or Use Problem1
- Degraded1
Patient problems
- Injury2
- Unspecified Infection2
- Inadequate Osseointegration1
- Osteolysis1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 27, 2026Degraded; Adverse Event Without Identified Device or Use Problem
THE FOLLOWING INFORMATION WAS PROVIDED: POLY WAS PITTED AND FEMUR HAD NO ROUGH SPOTS OR ANY BLEMISHES THAT WOULD¿VE CAUSED IT. REVISION PERFORMED. UPDATE: LEFT KNEE REVISION FOR POSSIBLE FEMORAL LOOSENING, CAUSE UNKNOWN BUT SUSPECTED TO BE ASEPTIC LOOSENING UNTIL POLY WAS DISCOVERED AND THOUGHT OF POTENTIAL OSTEOLYSIS BEING THE CAUSE.
Patient problems: Inadequate Osseointegration; Osteolysis
MAUDE report 25300330 ↗InjuryMay 16, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED A STAGE 1 REVISION WAS PERFORMED ON PATIENT'S LEFT KNEE. AN IRRIGATION AND DEBRIDEMENT WAS PERFORMED, ALL TKA COMPONENTS WERE REMOVED AND AN ANTIBIOTIC SPACER WAS PLACED. REP PROVIDED THE PRIMARY IMPLANT SHEET AND REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Injury; Unspecified Infection
MAUDE report 8616061 ↗InjurySep 22, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION IMPLANT SHEET THAT PATIENT'S LEFT KNEE WAS REVISED. A 7X11 TS INSERT WAS REVISED TO A 7X9 TS INSERT. REP CONFIRMED THAT A WASHOUT AND POLY SWAP WAS PERFORMED DUE TO INFECTION.
Patient problems: Injury; Unspecified Infection
MAUDE report 7900556 ↗
Other PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER devices
- ATTUNE 1512-14-050Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER106 reports
- ATTUNE 1504-40-205Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall53 reports
- ATTUNE 1504-40-105Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall46 reports
- ATTUNE 1547-06-001Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall37 reports
- ATTUNE 1513-12-060Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER72 reports
- Triathlon 5521-B-300Howmedica Osteonics Corp. · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall19 reports
- Triathlon 5531-G-709-EHowmedica Osteonics Corp. · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall19 reports
- ATTUNE 1512-16-080Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall16 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.
How reports and recalls are matched · Editorial policy · Report an error on this page