Triathlon 5531-G-611Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 07613327045956), received between Mar 1, 2017 and Dec 17, 2025 — classified as 15 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (7 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.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryDec 17, 2025Unstable; Unstable

  NO NEW INFORMATION.

  Patient problems: Joint Laxity

  MAUDE report 23830683 ↗
• InjuryApr 24, 2023Degraded; Fracture; Naturally Worn; Degraded; Fracture; Naturally Worn

  IT WAS REPORTED, "PATIENT NEEDS PATELLA COMPONENT. WHEN THE SURGEON OPENED THE KNEE HE COULD SEE THAT THE POSTERIOR PART OF THE INSERT HAD WEAR AND WAS BROKEN."

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16797224 ↗
• InjuryDec 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A POLY EXCHANGE WAS PERFORMED ON THE PATIENT'S LEFT KNEE DUE TO INFECTION. A TRIATHLON 6X11 CS POLY WAS REVISED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 15957083 ↗
• InjuryApr 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOW-UP OF TRIATHLON TRITANIUM OUTCOMES STUDY, PATIENT REPORTED DISSATISFACTION WITH THEIR KNEE REPLACEMENT. ADDITIONAL COMMENTS: "NOT HAPPY, HURTS."

  Patient problems: Pain

  MAUDE report 14186449 ↗
• InjuryFeb 28, 2022Fracture; Fracture

  AS REPORTED: "REVISION SURGERY. SURGEON REPLACED 6X11 PS INSERT WITH SAME SIZE. POST BROKE ON ORIGINAL INSERT."

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 13618856 ↗
• InjuryJan 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DR. REVISED A TRIATHLON TIBIAL INSERT ORIGINALLY DONE BY DR. AT KENT HOSPITAL AT AN UNKNOWN DATE. HE REVISED FROM A 6X11 TO A 6X9 DUE TO SCAR TISSUE AND TIGHTENING OF SOFT TISSUE.

  Patient problems: Loss of Range of Motion

  MAUDE report 13169930 ↗
• InjuryFeb 1, 2021Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A STAGE 1 REVISION WAS PERFORMED ON THE PATIENT'S LEFT KNEE DUE TO INFECTION. ALL COMPONENTS WERE REMOVED AND A SPACER WAS PLACED. REP PROVIDED THE PRIMARY USAGE SHEET AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 11257891 ↗
• InjuryAug 31, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  PROCEDURE: THE PATIENT UNDERWENT LEFT KNEE PRIMARY OSTEOARTHRITIS (B)(6) 2015. PATIENT UNDERWENT RIGHT TOTAL KNEE REVISION SURGERY FOR THE INFECTION (B)(6) 2020. ONLY POLY EXCHANGED.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 10472356 ↗
• InjuryJun 19, 2020Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO INSTABILITY. A 6X11 CS INSERT WAS REVISED TO A 6X13 CS INSERT. REP PROVIDED PRIMARY AND REVISION USAGE AND REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Injury

  MAUDE report 10173258 ↗
• MalfunctionSep 9, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  A TRIATHLON IMPLANT TRIATHLON CS X3 INSERT #6 11MM WHICH WAS EXPOSED TO WATER AND STEAM AT (B)(6) HOSPITAL WAS REDISTRIBUTED BY STRYKER AUSTRALIA AND SUBSEQUENTLY IMPLANTED DURING A PROCEDURE AT (B)(6) HOSPITAL. A FULL LOAN TRIATHLON IMPLANT SET WAS ACCIDENTALLY RETRIEVED FROM A HOSPITAL BY A COURIER AND WAS RETURNED TO A STRYKER KIT ROOM. HOWEVER, THE COURIER WAS UNAWARE THAT THE ITEMS WERE AFFECTED AND THEREFORE DID NOT COMMUNICATE TO THE KIT ROOM THAT THESE PARTS WERE PREVIOUSLY QUARANTINED AT THE HOSPITAL. AS A RESULT THE KIT ROOM DID NOT PROCEED WITH ANY QUARANTINE ACTION AND 18 OF THE AFFECTED ITEMS WERE RE-DISTRIBUTED. UPDATE 19/AUGUST/2019: NONE OF THE PACKAGING WAS RETAINED FROM THE IMPLANTED DEVICES. SURGEONS EXPRESSED NO CONCERN, AND HAVE COMMUNICATED NO PLANS TO SURGICALLY ADDRESS THE IMPLANTATION OF THE DEVICES. TO DATE, NO ADVERSE CONSEQUENCES HAVE BEEN REPORTED FOR THESE PATIENTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8974453 ↗
• InjuryAug 15, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT SOUGHT TREATMENT FOR POST TKA PAIN AND LACK OF ROM. KNEE WAS EXPLORED AND NO LOOSENING WAS OBSERVED, NEITHER WAS ANY SIGN OF INFECTION. SCAR TISSUE WAS REMOVED AND POLY INSERT 2MM THINNER WAS IMPLANTED.

  Patient problems: Ambulation or Postural Difficulties; Injury; Pain

  MAUDE report 8896555 ↗
• InjuryApr 17, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  REVISION OF RIGHT KNEE. DURING THE PRIMARY IMPLANTATION THE PATIENT WAS LEFT WITH 10 DEGREES HYPEREXTENSION. DURING THE REVISION SURGEON REPLACED ALL PARTS EXCEPT PATELLA, AND AUGMENTS AND STEM WERE ADDED.

  Patient problems: Ambulation or Postural Difficulties; Injury

  MAUDE report 8525135 ↗
• InjuryOct 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT HAD A RIGHT KNEE REVISION AND RE IMPLANTATION ON (B)(6) 2018, DUE TO [PERIPROSTHETIC JOINT INFECTION], ALL COMPONENTS EXCHANGED.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7969492 ↗
• InjuryJul 9, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT UNDERWENT BILATERAL TKA (B)(6) 2017 AND UNDERWENT REVISION FOR (B)(6) INFECTION (B)(6) 2018. ALL REPORTED DEVICES WERE REVISED.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7669881 ↗
• InjuryMay 14, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "PATIENT HAD UNACCEPTABLE PAIN AND CAME IN TO SEE DR ON (B)(6) 2018. HE PRESENTED WITH A 10 CM ARTHRODESIS WITH 3-4+ EFFUSION. ON (B)(6) 2018 IRRIGATION, DEBRIDEMENT, EVACUATION OF HEMATOMA AND TIBIAL LINER EXCHANGE WAS PERFORMED. FLUID AND TISSUE WAS COLLECTED TO BE SENT FOR TESTING. FLUID TESTED POSITIVE FOR SERRATIA MARRESCENS".

  Patient problems: Hematoma; Pain; Unspecified Infection

  MAUDE report 7510479 ↗
• InjuryMar 1, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PAINFUL LEFT TOTAL KNEE. LEFT KNEE OPEN DEBRIDEMENT. POLY EXCHANGE.

  Patient problems: Injury; Pain

  MAUDE report 6370532 ↗