Triathlon 5531-G-316-ERecalls & reported problems

Howmedica Osteonics Corp. · Tibial Bearing Insert - CS · 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 07613327337006), received between Dec 5, 2022 and Jul 21, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Unstable” (2 reports).

7 other recalls cover devices cleared under the same FDA submission (K172634); 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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Unstable2

Patient problems

Joint Laxity2
Fall1

Recent adverse event reports

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

InjuryJul 21, 2024Unstable; Unstable
PATIENT WITH GLOBALLY UNSTABLE RIGHT KNEE NOW S/P REVISION RTKA. NO ADDITIONAL DETAILS PROVIDED BY THE FACILITY.
Patient problems: Joint Laxity
MAUDE report 19788923 ↗
InjuryDec 5, 2022Unstable; Unstable
THE FOLLOWING WAS REPORTED: REVISED A 3X16 CS TIBIAL INSERT OF A LEFT KNEE. HE REVISED IT TO A 3X19 DUE TO MID-FLEXION AND FLEXION INSTABILITY. HE SAID THE PATIENT TOOK A FALL IN THE SUMMER TIMEFRAME AND SYMPTOMS PROGRESSED FROM THERE. NO ALLEGATIONS MADE AGAINST THE IMPLANTS.
Patient problems: Fall; Joint Laxity
MAUDE report 15914217 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K172634. One submission often covers many models, so check the product and lot details in each record.

Z-1266-2024 · Feb 6, 2024 · Open, Classified
NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM
Z-1265-2024 · Feb 6, 2024 · Open, Classified
NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM
Z-1263-2024 · Feb 6, 2024 · Open, Classified
NO 3 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
Z-1264-2024 · Feb 6, 2024 · Open, Classified
NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
Z-1262-2024 · Feb 6, 2024 · Open, Classified
X3 TRIATHLON CS INSERT NO 7 9 MM
Z-1261-2024 · Feb 6, 2024 · Open, Classified
X3 TRIATHLON CS INSERT NO 6 11 MM
Z-1654-2023 · Apr 13, 2023 · Open, Classified
TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM Intended for knee replacement Catalog Number: 5532-G-413-E

Device details

UDI-DI	`07613327337006`
Brand	Triathlon
Model	5531-G-316-E
Company	Howmedica Osteonics Corp.
Product code	JWH · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
Class	Class 2
FDA submission	K172634
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	May 3, 2022

Device type (GMDN): Tibial insert

An implantable device designed to articulate the femoral and tibial components of a knee joint prosthesis during primary or revision bicondylar knee joint replacement. It is typically a one-piece contoured polyethylene (PE) insert, or a more complex device (e.g., a guide arm with a stem that is inserted into the tibial tray and a polymer glide) which will better reproduce the flexion of the knee joint due to its capacity for lateral rotation and anterior/posterior movement. This device is typically made of metal and/or a polymer.

Other PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices

ATTUNE 1506-00-005
Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
589 reports
ATTUNE 1506-00-004
Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
580 reports
JOURNEY 74012812
Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
502 reports
JOURNEY 74011856
Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
438 reports
PERSONA™ 42-5099-094-00
Zimmer, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
406 reports
JOURNEY 74011857
Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
388 reports
ATTUNE 1506-00-007
Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
288 reports
ATTUNE 1506-00-003
Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
271 reports

All PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices →

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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