Triathlon 5532-G-510-ERecalls & reported problems
Howmedica Osteonics Corp. · Tibial Bearing Insert - PS · Class 2 · Implant
All models of Triathlon (608)
Data updated Oct 16, 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 07613327390971), received between Sep 9, 2022 and Nov 13, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Unstable” (1 report).
3 other recalls cover devices cleared under the same FDA submission (K173849); they may or may not involve this specific model.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Unstable1
Patient problems
- Fall1
- Joint Laxity1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 13, 2025Unstable; Unstable
THE FOLLOWING INFORMATION WAS PROVIDED: LEFT KNEE REVISION, PATIENT PRESENTED WITH INSTABILITY FOLLOWING AN ORIGINAL TKA. SURGEON SWAPPED THE POLY AND ALL OTHER COMPONENTS WERE LEFT IN-SITU AT THIS TIME. NO COMPLAINTS FILED AGAINST THE COMPONENTS THEMSELVES, AND NO FURTHER INFORMATION AVAILABLE.
Patient problems: Joint Laxity
MAUDE report 23543447 ↗InjurySep 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT'S LEFT KNEE WAS REVISED. ONE DAY POST PRIMARY IMPLANT, PATIENT FELL AND OPENED THE SURGICAL WOUND. SURGEON DECIDED TO PERFORM AN I&D WITH POLY EXCHANGE PROPHYLACTICALLY AGAINST INFECTION (INFECTION WAS NOT SUSPECTED). REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Fall
MAUDE report 15394029 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K173849. One submission often covers many models, so check the product and lot details in each record.
- Z-1260-2024 · Feb 6, 2024 · Open, ClassifiedX3 TRIATHLON CS INSERT NO 6 10 MM
- Z-1259-2024 · Feb 6, 2024 · Open, ClassifiedX3 TRIATHLON CS INSERT NO 3 10 MM
- Z-1653-2023 · Apr 13, 2023 · Open, ClassifiedTRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM-Intended for knee replacement Catalog Number: 5531-G-312-E
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 5531-G-709-EHowmedica Osteonics Corp. · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall19 reports
- Triathlon 5521-B-300Howmedica Osteonics Corp. · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall19 reports
- Triathlon 5531-G-610-EHowmedica Osteonics Corp. · 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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