Triathlon 5530-G-411Recalls & reported problems
Howmedica Osteonics Corp. · Tibial Bearing Insert - CR · Class 2 · Implant
All models of Triathlon (608)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Triathlon knee bearing insert sits between the metal parts of a knee replacement to allow smooth movement. Reports mostly describe knee instability and wear that led to revision surgery to replace the insert. There are 24 adverse event reports naming its identifier, mentioning 24 injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 24
- Deaths reported
- 0
- Injuries reported
- 24
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 07613327050486), received between Nov 2, 2017 and Jan 15, 2025 — classified as 24 injuries.
The most frequently reported specific device problem is “Unstable” (13 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
- Unstable13
- Insufficient Device Problem Information9
- Degraded5
- Fracture3
- Naturally Worn2
- Material Deformation1
- Material Distortion1
- Material Erosion1
Patient problems
- Injury14
- Joint Laxity10
- Fall3
- Unspecified Infection3
- Pain2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
InjuryJan 15, 2025Degraded; Degraded
IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INSTABILITY. A 4X11 CR INSERT WAS REVISED TO A 4X11 CS INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Joint Laxity
MAUDE report 21164494 ↗InjuryJul 10, 2024Degraded; Unstable; Degraded; Unstable
REVISION SURGERY OF A LEFT TOTAL KNEE DUE TO INSTABILITY IN THE JOINT. THE 11MM INSERT WAS REMOVED AND A 19MM INSERT WAS IMPLANTED. NO INFORMATION FROM THE INDEX SURGERY IS AVAILABLE. NO FURTHER INFORMATION AVAILABLE FROM THE DOCTOR OR HOSPITAL.
Patient problems: Joint Laxity
MAUDE report 19712124 ↗InjuryAug 24, 2023Degraded; Unstable; Degraded; Unstable
PLEASE FIND ATTACHED INFORMATION FROM A RIGHT TOTAL KNEE REVISION DONE SECONDARY TO PAIN AND INSTABILITY. NO FURTHER INFORMATION IS AVAILABLE FROM THE DOCTOR OR HOSPITAL.
Patient problems: Joint Laxity; Pain
MAUDE report 17620858 ↗InjuryNov 23, 2022Degraded; Fracture; Unstable; Degraded; Fracture; Unstable
"KNEE REVISION DUE TO INSTABILITY" WAS REPORTED.
Patient problems: Joint Laxity
MAUDE report 15850888 ↗InjuryMar 8, 2022Degraded; Unstable; Naturally Worn; Degraded; Unstable; Naturally Worn
InjuryNov 17, 2021Material Erosion; Fracture; Unstable; Material Erosion; Fracture; Unstable
InjuryJul 7, 2021Unstable; Unstable
IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO PAIN AND INSTABILITY. PATIENT WAS REVISED FROM A 4X11 INSERT TO A 4X16 INSERT. REP REPORTED THAT ALL AVAILABLE INFORMATION HAS BEEN SUBMITTED.
Patient problems: Joint Laxity
MAUDE report 12127880 ↗InjuryJun 15, 2021Unstable; Unstable
REVISION OF INSERT DUE TO INSTABILITY.
Patient problems: Joint Laxity; No Clinical Signs, Symptoms or Conditions
MAUDE report 12002707 ↗InjuryMar 30, 2021Unstable; Unstable
InjuryAug 26, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT A STAGE 1 REVISION WAS PERFORMED ON THE PATIENT'S LEFT KNEE DUE TO PVNS (PIGMENTED VILLONODULAR SYNOVITIS, THE SYNOVIUM THICKENS AND OVERGROWS INTO A MASS OR TUMOR) AND SUSPECTED INFECTION AFTER THE PATIENT FELL. ALL DEVICES WERE REMOVED AND A SPACER PLACED PRIOR TO PERFORMING RADIATION TREATMENT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Injury; Unspecified Infection
MAUDE report 10454658 ↗InjuryJul 21, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THROUGH THE SUBMISSION OF A PRIMARY AND REVISION USAGE SHEET THAT THE PATIENT'S LEFT KNEE WAS REVISED. A TRIATHLON X3 TIBIAL BEARING, TRIATHLON X3 TIBIAL SYMMETRIC PATELLA, TRIATHLON PRIMARY TIBIAL BASEPLATE, AND TRIATHLON CR WERE REVISED TO A TRIATHLON X3 TIBIAL BEARING, TRIATHLON TOTAL KNEE CEMENTED STEM AND UNIVERSAL BASEPLATE, AND A TRIATHLON PS.
Patient problems: Injury
MAUDE report 10300859 ↗InjuryJun 22, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
VIOLENCE, OVERTURNING BY BICYCLE. UPDATE PER EMAIL RECEIVED: "DURING THE OVERTURN, THE KNEE WAS TWISTED WITH FORCE THE PATIENT WAS REOPERATED WERE THEY CHANGED THE INSERT."
Patient problems: Fall; Injury; Joint Laxity
MAUDE report 10178708 ↗InjuryFeb 10, 2020Unstable; Unstable
InjuryFeb 10, 2020Unstable; Unstable
InjuryDec 11, 2019Unstable; Unstable
PATIENT HAD A REVISION OF POLY INSERT DUE TO INSTABILITY. PATIENT HAD A TRAUMATIC FALL 1 YEAR AGO WITH TWISTING FORCE. WIGHT GAIN SINCE PRIMARY SURGERY 20 KG.
Patient problems: Fall; Injury
MAUDE report 9452553 ↗InjuryDec 11, 2019Unstable; Unstable
REVISION DUE TO INSTABILITY. PATIENT HAD AN ACCIDENT 1,5 YEAR AGO WHEN WALKING IN FOREST AND HAD A FALL WITH TWIST.
Patient problems: Fall; Injury
MAUDE report 9452428 ↗InjuryApr 24, 2019Unstable; Naturally Worn; Unstable; Naturally Worn
InjuryApr 9, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO PATIENT COMPLAINT OF CLICKING. SURGEON PERFORMED A DEBRIDEMENT AND REMOVAL OF A BONY PROMINENCE, AND EXCHANGED THE LINER. REP REPORTED THAT THE SURGEON AND HOSPITAL WILL NOT RELEASE ANY FURTHER INFORMATION.
Patient problems: Injury
MAUDE report 8496673 ↗InjuryMar 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INFECTION (INFECTION REPORTED BY SURGEON, UNKNOWN IF CLINICALLY CONFIRMED OR IDENTIFIED). SURGEON REVISED A 4X11 CR INSERT TO A 4X11 CS INSERT.
Patient problems: Injury; Unspecified Infection
MAUDE report 8452382 ↗InjuryFeb 4, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT A DEBRIDEMENT AND POLY SWAP WAS PERFORMED ON PATIENT'S LEFT KNEE DUE TO SUSPECTED INFECTION. SURGEON REPORTED THAT PATIENT HAD HAD A RECENT URINARY TRACT INFECTION AND SUSPECTS IT AS A POSSIBLE CAUSE/ CONTRIBUTOR. IT WAS NOT REPORTED TO THE REP IF THE INFECTING MICROORGANISM WAS CLINICALLY CONFIRMED OR IDENTIFIED. A 4X11 CR INSERT WAS REVISED TO A 4X9 CR INSERT AS THE SURGEON ALSO FELT THE PATIENT'S KNEE WAS A LITTLE TOO TIGHT.
Patient problems: Injury; Unspecified Infection
MAUDE report 8302247 ↗InjuryAug 16, 2018Fracture; Fracture
IT WAS REPORTED THAT PATIENT'S RIGHT KNEE WAS REVISED AFTER PATIENT COMPLAINED OF HEARING A LOUD SNAP OR CRACK IN HIS KNEE. SURGEON REVISED ON SUSPICION OF A FRACTURED POLY INSERT. INTRA-OPERATIVELY, THE SUSPICION WAS CONFIRMED AND THE INSERT WAS REVISED.
Patient problems: Injury
MAUDE report 7789290 ↗InjuryJun 25, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
PATIENT REPORTED THAT SHE HAD BILATERAL TKA, RIGHT KNEE WAS DONE ON (B)(6) 2009 AND LEFT KNEE (B)(6) 2009. PATIENT STARTED TO EXPERIENCE PAIN IN 2012. THIS PI IS FOR RIGHT KNEE.
Patient problems: Pain
MAUDE report 7634871 ↗InjuryMay 23, 2018Material Deformation; Insufficient Device Problem Information; Material Deformation; Insufficient Device Problem Information
PATIENT NEEDED KNEE REVISION. THE REASON IS ¿INSTABILITY¿ IN THE KNEE.
Patient problems: Injury
MAUDE report 7537882 ↗InjuryNov 2, 2017Material Distortion; Scratched Material; Insufficient Device Problem Information; Material Distortion; Scratched Material; Insufficient Device Problem Information
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