Triathlon 5537-G-325Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327027181), received between Dec 26, 2018 and Sep 3, 2024 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT FROM CONES STUDY COMPLETED THEIR 6YR FOLLOW-UP VISIT IN THE DOCTOR'S OFFICE ON (B)(6) 2023. COMPLETED THE FOLLOW-UP QUESTIONNAIRE. ANSWERED "YES" FOR QUESTION "DO YOU HAVE ANY PAIN IN YOUR KNEE THAT HAS THE STUDY KNEE REPLACEMENT?" AND "NO" FOR QUESTION "ARE YOU SATISFIED WITH THE RESULTS OF YOUR STUDY KNEE REPLACEMENT?". SUBJECT HAS NOT HAD ANY SURGERY SINCE THE LAST STUDY REQUIRED VISIT. ADDITIONAL COMMENTS NOTED, PAIN WHEN I WALK A LOT/LIFE TOO MUCH/TWIST IT WRONG. YES AND NO TO BEING SATISFIED WITH THE RESULTS OF YOUR KNEE REPLACEMENT. HAVE TO USE A WALKER BETTER THAN NOT BEING ABLE TO WALK AT ALL LIKE BEFORE THE SURGERY. RADIOGRAPHS WERE NOT COLLECTED DURING THE VISIT.

  Patient problems: Pain

  MAUDE report 20127457 ↗
• InjuryMay 30, 2023Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INSTABILITY. SURGEON REPORTED THE PATIENT SUBLUXED OVER THE POST OF THE INSERT AND THAT HE SUSPECTS THAT THIS WAS DUE TO LIGAMENT LOOSENING. A 3X25 TS INSERT WAS EXCHANGED FOR A 3X28 TS INSERT.

  Patient problems: Joint Laxity

  MAUDE report 17019273 ↗
• MalfunctionJun 18, 2020Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT DURING A REVISION OF THE PATIENT'S RIGHT KNEE, THE LOCKING WIRE OF THE INSERT CAME OUT WHILE POSITIONING THE INSERT (CAUGHT ON THE ANTERO-LATERAL CLIP OF THE BASEPLATE). AS NO REPLACEMENT WAS AVAILABLE IN THE OPERATING ROOM, THE SURGEON DECIDED TO IMPLANT THE NOW WIRE-LESS INSERT AND INSERTED THE STABILIZER PIN FURTHER INTO THE BASEPLATE. SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 5 MINUTES. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10166677 ↗
• InjuryMay 23, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY ON OR ABOUT (B)(6)2018 THE PATIENT UNDERWENT KNEE REPLACEMENT SURGERY WHICH WAS A SUBSTANTIAL FACTOR IN CAUSING THE INJURIES WHICH THE PATIENT SUFFERS.

  Patient problems: Injury

  MAUDE report 8636836 ↗
• InjuryFeb 28, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDICAL REVIEW STATES THAT POST OPERATIVELY THE PATIENT HAD PERSISTENT DRAINAGE AND ON (B)(6) 2017 SHE UNDERWENT AN IRRIGATION AND DEBRIDEMENT OF THIS REVISION TKA.

  Patient problems: Unspecified Infection

  MAUDE report 8379778 ↗
• InjuryDec 26, 2018Unstable; Unstable

  AS REPORTED: "THIS PATIENT IS CURRENTLY A SUBJECT IN STRYKER'S TRIATHLON TRITANIUM CONE AUGMENTS OUTCOMES STUDY. ALL INFORMATION COMES FROM A DATABASE FOR SAID STUDY. ON (B)(6) 2018, THE PATIENT WAS COMPLAINING OF LITTLE INSTABILITY, BUT HAD NO KNOWN INJURY. THE PATIENT WAS EXPERIENCING JOINT LAXITY (GRADE 1+ ON ANTERIOR DRAWER TEST), HAD MID FLEXION INSTABILITY AND MID FLEXION STRESS. THE PATIENT RECEIVED A BRACE WITH METAL STAYS THE SAME DAY, AND EVENTUALLY HAD THE POLY LINER REVISED ON (B)(6) 2018.

  Patient problems: Injury

  MAUDE report 8196333 ↗