Triathlon 5537-G-216-ERecalls & reported problems

Howmedica Osteonics Corp. · Total Stabilizer+ Tibial Insert · 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 07613327288261), received between Jan 3, 2024 and Nov 25, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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

Adverse Event Without Identified Device or Use Problem1
Detachment of Device or Device Component1
Device Dislodged or Dislocated1

Patient problems

Insufficient Information1
Unspecified Infection1

Recent adverse event reports

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

InjuryNov 25, 2025Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated
THE FOLLOWING INFORMATION WAS REPORTED: IMPLANTATION SURGERY TOOK PLACE ON (B)(6) 2025. X-RAY RADIOGRAPHY WAS TAKEN APPROXIMATELY ONE MONTH PRIOR TO REVISION SURGERY, WHICH REVEALED THE LOOSENED INSERT. THE INSERT BECAME LOOSE; THUS, A REVISION SURGERY TOOK PLACE ON (B)(6) 2025 FOR REMOVAL AND REPLACEMENT OF INSERT T.S.
Patient problems: Insufficient Information
MAUDE report 23642586 ↗
InjuryJan 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
FULL EXPLANT TO STATIC SPACER OF A CHRONICALLY INFECTED TS LEFT KNEE. THE PATIENT HAD MULTIPLE IDS.
Patient problems: Unspecified Infection
MAUDE report 18437819 ↗

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-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-1266-2024 · 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-1265-2024 · Feb 6, 2024 · Open, Classified
NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 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	`07613327288261`
Brand	Triathlon
Model	5537-G-216-E
Company	Howmedica Osteonics Corp.
Product code	MBH · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, 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 10, 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, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER devices

ATTUNE 1512-14-050
Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
106 reports
ATTUNE 1504-40-205
Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
1 recall53 reports
ATTUNE 1504-40-105
Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
1 recall46 reports
ATTUNE 1547-06-001
Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
1 recall37 reports
ATTUNE 1513-12-060
Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
72 reports
Triathlon 5531-G-709-E
Howmedica Osteonics Corp. · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
1 recall19 reports
Triathlon 5521-B-300
Howmedica Osteonics Corp. · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
1 recall19 reports
Triathlon 5531-G-610-E
Howmedica Osteonics Corp. · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
1 recall16 reports

All PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, 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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