Triathlon 5531-G-409Recalls & reported problems
Howmedica Osteonics Corp. · Tibial Bearing Insert · Class 2 · Implant
All models of Triathlon (608)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Howmedica Osteonics Triathlon tibial bearing insert is the plastic cushion inside a knee replacement. The 45 reports mostly describe the insert wearing down or shifting, leaving the metal parts of the knee rubbing together, along with pain and infection that led to revision surgery, where surgeons swapped in a larger or new insert. No deaths were reported and 40 injuries were. 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
- 45
- Deaths reported
- 0
- Injuries reported
- 40
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 07613327045802), received between Feb 9, 2017 and Dec 3, 2025 — classified as 40 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (22 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 Information22
- Unstable10
- Adverse Event Without Identified Device or Use Problem5
- Degraded4
- Device Contamination with Chemical or Other Material1
- Device Operates Differently Than Expected1
- Device Slipped1
- Difficult to Insert1
Patient problems
- Injury19
- Pain14
- Unspecified Infection10
- Ambulation or Postural Difficulties6
- Aspiration/Inhalation5
- Insufficient Information5
- Joint Laxity4
- No Known Impact Or Consequence To Patient4
Recent adverse event reports
The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.
InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INFECTION. AN I&D WITH WASHOUT AND POLY SWAP OF A 4X9 CS INSERT WAS PERFORMED.
Patient problems: Unspecified Infection
MAUDE report 23708911 ↗InjuryNov 19, 2025Unstable; Unstable
AS REPORTED: "PATIENT IS S/P REV RTKA DUE TO INSTABILITY. NO ADDITIONAL DETAILS TO BE REPORTED BY THE FACILITY." A CR/ CS KNEE WAS CONVERTED TO A TS KNEE WITH STEMS AND AUGMENTS.
Patient problems: Joint Laxity
MAUDE report 23592867 ↗InjuryOct 29, 2025Degraded; Fracture; Degraded; Fracture
IT WAS REPORTED THE PATIENT'S LEFT KNEE WAS REVISED. PATIENT PRESENTED WITH COMPLAINT OF PAIN AND A SUPERFICIAL WOUND INFECTION, AND REPORTED A PRIOR FALL AND A BUG BITE. UPON OPENING THE JOINT, METAL-STAINED TISSUE WAS OBSERVED, AS WELL AS POSTERIOR LATERAL WEAR OF THE INSERT TO THE POINT WHERE THE FEMORAL COMPONENT WAS ARTICULATING AGAINST THE BASEPLATE. SURGEON SUSPECTED THE FALL MAY HAVE DISRUPTED THE SOFT TISSUES OR SHIFTED THE IMPLANTS, CAUSING THE UNEVEN WEAR. THOUGH NO LAB RESULTS CAME BACK TO INDICATE WHETHER THE JOINT WAS INFECTED OR NOT, ALL COMPONENTS WERE REMOVED AND AN ANTIBIOTIC SPACER WAS PLACED AS A PRECAUTIONARY MEASURE. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Fall; Metal Related Pathology; Pain; Unspecified Infection
MAUDE report 23417534 ↗InjurySep 3, 2024Unstable; Unstable
IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO INSTABILITY. A 4X9 CS INSERT WAS REVISED TO A 4X12 CS INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Joint Laxity
MAUDE report 20124268 ↗InjuryAug 6, 2024Degraded; Degraded
IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO PAIN AND INFLAMMATION. A 4X9 CS INSERT WAS EXCHANGED FOR ANOTHER 4X9 CS INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Pain; Swelling/ Edema
MAUDE report 19916603 ↗InjuryMay 20, 2024Unstable; Unstable
REVISED THE TIBIAL INSERT OF A LEFT TRIATHLON DUE TO POSTERIOR INSERT WEAR/INSTABILITY FROM PCL RUPTURE. HE UPSIZED FROM A 4X9 TO 4X10.
Patient problems: Insufficient Information
MAUDE report 19349797 ↗InjurySep 22, 2023Degraded; Unstable; Degraded; Unstable
DAMAGED X3 INSERT RETRIEVED DURING POLYETHYLENE EXCHANGE FOR KNEE PAIN / INSTABILITY.
Patient problems: Joint Laxity; Pain
MAUDE report 17803136 ↗InjuryApr 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO POSSIBLE INFECTION. A 4X9 CS INSERT WAS REMOVED AND A 4X10 CS INSERT WAS IMPLANTED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Unspecified Infection
MAUDE report 16820531 ↗InjuryOct 12, 2022Pitted; Pitted
IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO TIBIAL SUBSIDENCE. INTRA-OPERATIVELY, THE SURGEON NOTED THAT THERE APPEARED TO BE PITTING IN THE POLY. THE BASEPLATE AND INSERT WERE REVISED.
Patient problems: Insufficient Information
MAUDE report 15585302 ↗InjuryJun 7, 2022Unstable; Unstable
THE FOLLOWING WAS REPORTED: 9MM TIBIAL INSERT WAS EXPLANTED AND AN 11MM INSERT WAS IMPLANTED TO ADDRESS INSTABILITY.
Patient problems: Joint Laxity
MAUDE report 14617123 ↗InjuryMay 9, 2022Degraded; Insufficient Device Problem Information; Degraded; Insufficient Device Problem Information
THE FOLLOWING WAS REPORTED: KNEE REVISION.
Patient problems: Insufficient Information
MAUDE report 14342957 ↗InjuryDec 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED: PATIENTS LEFT KNEE POLY WAS SWAPPED DUE TO INFECTION. INITIAL OP DATE WAS (B)(6) 2018.
Patient problems: Unspecified Infection
MAUDE report 12907211 ↗InjuryOct 27, 2021Unstable; Unstable
AS REPORTED: "REVISION WAS PERFORMED FOR INSTABILITY OF THE JOINT IN EXTENSION. NO OTHER INFORMATION AVAILABLE FROM THE HOSPITAL." LEFT KNEE. PATIENT WAS REVISED FROM A CS TIBIAL INSERT AND CR FEMORAL COMPONENT TO A PS TIBIAL INSERT AND A TS FEMORAL COMPONENT WITH AUGMENTS AND A STEM.
Patient problems: Insufficient Information
MAUDE report 12704308 ↗InjuryDec 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO SUSPECTED INFECTION. A LINER EXCHANGE AND WASHOUT WAS DONE. SURGEON ALSO WENT FROM A 4X9 CS INSERT TO A 4X16 CS INSERT. THE REP REPORTED THAT THE SURGEON THOUGHT A THICKER INSERT WOULD BE MORE STABLE, BUT NO PRIOR INSTABILITY WAS REPORTED. THE REP CONFIRMED THAT NO FURTHER INFORMATION WOULD BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Unspecified Infection
MAUDE report 10975599 ↗InjuryNov 16, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO RIGHT KNEE PAIN.
Patient problems: Pain
MAUDE report 10842936 ↗InjuryNov 15, 2020Loss of Osseointegration; Insufficient Device Problem Information; Loss of Osseointegration; Insufficient Device Problem Information
IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO A FAILED LEFT TOTAL KNEE ARTHROPLASTY. 16 DEC 2020 , AS PER MEDICAL REVIEW "TIBIAL WAS GROSSLY LOOSE ", OTHER DEVICES WILL THEREFORE BE CONSIDERED CONCOMITANT
Patient problems: Inadequate Osseointegration; Insufficient Information
MAUDE report 10841558 ↗InjuryJun 19, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
INFORMATION RECEIVED INCLUDES A REPORT DATED (B)(6) 2013: "UNFORTUNATELY, SHE HAD A FALL A WEEK BACK AND SINCE THEN HER KNEE HAS BEEN SWOLLEN...WITH REGARDS TO HER HEMARTHROSIS, WE PROCEEDED TO ASPIRATE OUT ABOUT 70 CC OF BLOOD FROM HER KNEE JOINT UNDER ALL ASEPTIC PRECAUTIONS..."
Patient problems: Aspiration/Inhalation; Fall; Loss of Range of Motion
MAUDE report 10173123 ↗InjuryJun 19, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
INFORMATION RECEIVED INCLUDES A REPORT DATED (B)(6) 2013: "DIAGNOSIS: INFECTED RIGHT KNEE...THE KNEE IS RED AND SWOLLEN. THIS WAS PREPPED AND ASPIRATED OF 20 CC OF BLOODY FLUID. ALSO DURING THE PROCEDURE SHE HAD A LATERAL RELEASE..." PATIENT WAS PLACED ON ANTIBIOTICS.
Patient problems: Ambulation or Postural Difficulties; Aspiration/Inhalation; Inflammation; Pain; Swelling; Unspecified Infection
MAUDE report 10173122 ↗InjuryJun 18, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
INFORMATION RECEIVED IN FOLLOW-UP INCLUDES A REPORT DATED SEPTEMBER 11, 2013: "HER MAIN CONCERN TODAY IS THE EFFUSION THAT HAS BEEN BEHIND HER RIGHT KNEE. SHE NOTES THAT IT IS MODERATELY PAINFUL. 20 CC OF SEROSANGUINEOUS FLUID WERE DRAINED FROM THE KNEE."
Patient problems: Ambulation or Postural Difficulties; Aspiration/Inhalation; Inflammation; Pain
MAUDE report 10167530 ↗InjuryJun 18, 2020Unstable; Insufficient Device Problem Information; Unstable; Insufficient Device Problem Information
INFORMATION RECEIVED IN FOLLOW-UP INCLUDES A REPORT DATED (B)(6) 2014: "STILL WITH A FEELING OF INSTABILITY AND GIVING WAY. A THROUGH SUPEROMEDIAL PORTAL OF KNEE ASPIRATION OF INTRA-ARTICULAR FLUID WAS DONE WITH ABOUT 20CC FOLLOWED BY LIGHT DRESSING.''
Patient problems: Ambulation or Postural Difficulties; Aspiration/Inhalation; Fall
MAUDE report 10167527 ↗InjuryJun 18, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
INFORMATION RECEIVED IN FOLLOW-UP INCLUDES A REPORT DATED (B)(6) 2013: "...SHE HAS AN EFFUSION ABOUT THE RIGHT KNEE...SHE WAS ASPIRATED TODAY TAKING OUT APPROXIMATELY 20CC OF BLOOD-TINGED FLUID."
Patient problems: Ambulation or Postural Difficulties; Aspiration/Inhalation; Inflammation; Pain
MAUDE report 10167526 ↗InjuryMay 19, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT'S KNEE WAS REVISED. AS REPORTED BY REP: "REVISED FOR INFECTION. NO OTHER INFORMATION IS AVAILABLE PER HOSPITAL POLICY."
Patient problems: Injury; Unspecified Infection
MAUDE report 10072448 ↗InjuryMar 31, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
IMPLANTS REMOVED DUE TO INFECTION. DOCTOR STATED THAT THE INFECTION WAS SECONDARY TO AN INFECTION FROM PRESSURE SORES ON THE PATIENT.
Patient problems: Injury; Unspecified Infection
MAUDE report 9903783 ↗InjuryMar 24, 2020Naturally Worn; Insufficient Device Problem Information; Naturally Worn; Insufficient Device Problem Information
PATIENT HAD ORIGINAL KNEE DONE ON (B)(6) 2009 BY DR. AT HOSPITAL. PRESENTED TODAY FOR LEFT KNEE PAIN AND A POLY EXCHANGE BY DR.
Patient problems: Injury; Pain
MAUDE report 9872227 ↗InjuryMar 23, 2020Unstable; Unstable
IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INSTABILITY. A 4X9 CS INSERT AND CR FEMUR WERE REVISED TO A 4X11 PS INSERT AND PS FEMUR.
Patient problems: Injury
MAUDE report 9866445 ↗
Other PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices
- ATTUNE 1506-00-005Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER589 reports
- ATTUNE 1506-00-004Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER580 reports
- JOURNEY 74012812Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER502 reports
- JOURNEY 74011856Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER438 reports
- PERSONA™ 42-5099-094-00Zimmer, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER406 reports
- JOURNEY 74011857Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER388 reports
- ATTUNE 1506-00-007Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER288 reports
- ATTUNE 1506-00-003Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER271 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.
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