Triathlon 5531-G-613Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 07613327045949), received between Mar 29, 2017 and Jul 28, 2025 — classified as 12 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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.

• InjuryJul 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE IMPLANTED OVER 10 YEARS AGO WAS REVISED DUE TO A SUSPECTED INFECTION. A 6X13 CS INSERT WAS EXCHANGED FOR ANOTHER. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 22637802 ↗
• InjuryMar 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A POLY EXCHANGE DUE TO KNEE PAIN. PATIENT NOTED THAT THE PRIMARY WAS DONE IN ANOTHER LOCATION. NO ADDITIONAL INFORMATION AVAILABLE DUE TO HOSPITAL POLICY.

  Patient problems: Pain

  MAUDE report 21586597 ↗
• InjuryDec 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT PRIMARY RIGHT TKA OUTSIDE CORS SCOPE. ON (B)(6), 2021 THE PATIENT WAS REVISED FOR MECHANICAL LOOSENING. PATIENT PRESENTED WITH PAIN AND SIGNS OF PJI. WAS REVISED ON (B)(6), 2022. ALL COMPONENTS EXCHANGED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 15976780 ↗
• InjuryOct 21, 2021Adverse 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 FOR SUSPECTED INFECTION. A POLY SWAP WAS DONE. OTHER THAN THE PROVIDED REVISION USAGE SHEET, NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 12671784 ↗
• InjuryOct 2, 2020Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO INSTABILITY. A 6X13 CS INSERT WAS REVISED TO A 6X19 CS INSERT. REP PROVIDED THE REVISION USAGE SHEET AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 10619036 ↗
• InjurySep 15, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INFECTION. A 6X13 CS POLY WAS EXCHANGED FOR ANOTHER 6X13 CS POLY.

  Patient problems: Bacterial Infection

  MAUDE report 10534489 ↗
• MalfunctionMar 30, 2020Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  PRIMARY PROCEDURE, LEFT KNEE. IT WAS REPORTED THAT THE INSERT WOULD NOT SEAT INTO THE BASEPLATE. A 2ND IMPLANT OF THE SAME LOT CODE WAS OPENED AND SEATED, BUT ADDITIONAL EFFORT THAN NORMAL WAS REQUIRED. PROCEDURE COMPLETED SUCCESSFULLY WITH NO DELAY. THE WASTED INSERT IS ALLEGEDLY AVAILABLE FOR RETURN. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9897820 ↗
• InjuryFeb 12, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "LEFT KNEE REVISION. REVISION DONE DUE TO INFECTION. ALL IMPLANTS WERE EXPLANTED."

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9702562 ↗
• InjuryFeb 10, 2020Unstable; Unstable

  KNEE REVISION DUE TO INSTABILITY.

  Patient problems: Injury

  MAUDE report 9688502 ↗
• InjuryOct 15, 2019Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO INSTABILITY. A 6X13 CS INSERT WAS REVISED TO A 6X16 CS X3 INSERT. THE SURGEON NOTED THAT THE POLY HAD SOME YELLOWING AND WOULD LIKE TO ENSURE THAT IT IS NOT OXIDATION. THE EXPLANT IS AVAILABLE FOR RETURN, AND THE REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury; Limited Mobility Of The Implanted Joint

  MAUDE report 9191852 ↗
• MalfunctionSep 9, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  A TRIATHLON IMPLANT TRIATHLON CS X3 INSERT #6 13MM WHICH WAS EXPOSED TO WATER AND STEAM AT (B)(6) HOSPITAL, WAS REDISTRIBUTED BY STRYKER (B)(4) 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 8974456 ↗
• MalfunctionJul 1, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THERE IS A GAP BETWEEN THE INSERT AND TIBIA TRAY AFTER IMPACTION. THIS ISSUE WAS FOUND OUT DURING THE SURGERY. UPDATE: DELAY OF SURGERY: 20 MIN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8748038 ↗
• InjuryAug 6, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE SURGEON EXPLANTED TRIATHLON PRIMARY TKA IMPLANTS FROM A RIGHT INFECTED TOTAL KNEE AND PLACED A TEMPORARY SPACER. ORIGINAL SURGERY WAS (B)(6) 2018 AND AN I AND D WITH TIBIAL INSERT EXCHANGE WAS DONE ON (B)(6) 2018.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7754316 ↗
• InjuryApr 2, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  SURGEON DID AN I&D WITH INSERT EXCHANGE, DUE TO POSSIBLE INFECTION.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7390711 ↗
• InjuryMay 31, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  REVISION OF A PRIMARY KNEE WITH POLY SWAP DUE TO INFECTION.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 6600549 ↗
• MalfunctionMar 29, 2017Difficult to Insert; Mechanical Problem; Fitting Problem; Connection Problem; Difficult to Insert; Mechanical Problem; Fitting Problem

  POLY INSERT DIDN'T LOCK CORRECTLY IN BASEPLATE. THEY USED ANOTHER INSERT WHICH LOCKED INTO THE BASEPLATE WITH NO ISSUES. THEY DID NOT NEED TO EXCHANGE THE BASEPLATE.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 6444746 ↗