Triathlon 5541-A-402Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327015232), received between Jun 29, 2018 and May 27, 2021 — classified as 5 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 27, 2021Loss of Osseointegration; Loss of Osseointegration

  IN PERFORMING FOLLOW-UP, REP PROVIDED A REVISION OPERATIVE REPORT FOR (B)(6) 2013 FOR THE PATIENT'S RIGHT KNEE. PREOPERATIVE DIAGNOSIS: LOOSE RIGHT REVISION KNEE ARTHROPLASTY WITH MALTRACKING OF PATELLA. OP REPORT NOTES: "IN LESS THAN 1 YEAR SHE DEVELOPED INCREASING PAIN AND DISCOMFORT. STUDIES ARE SUSPICIOUS FOR POSSIBLE LOOSENING OF FEMORAL COMPONENT. THERE WAS ONLY SOME DISTAL CEMENT AROUND THE FEMORAL COMPONENT. THE STEM APPEARED TO BE REACTIVE LINE AROUND IT SUGGESTING LOOSENING OF FEMORAL COMPONENT...THE PATELLA WAS ALSO TILTING AND MALTRACKING¿FEMORAL COMPONENT CAME OUT VERY EASILY WITH NO FIXATION AT ALL. THE CEMENT WAS BONDED TO THE IMPLANT WITH AUGMENTS. THE STEM CAME OUT AND THERE WAS A FIBROUS MEMBRANE AROUND THE STEM COMPLETELY. THERE WAS NO CEMENT ON THE STEM AT ALL CONSISTENT WITH FEMORAL COMPONENT LOOSENING...WE HAD TO REMOVE THE PATELLAR COMPONENT TO POSITION IT MORE CENTRALLY..."

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 11899112 ↗
• InjuryApr 16, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED. AS REPORTED BY REP: "THIS IS A REVISION TO A REVISION DONE ON (B)(6) 2016 ((B)(6) 2016 REVISION WAS OF COMPETITOR DEVICES). THE CURRENT REVISION WAS DUE TO A SUSPECTED LOOSE FEMORAL COMPONENT, AS STATED BY SURGEON". A SIZE 4 TS FEMORAL COMPONENT WITH STEM AND AUGMENTS, AND A TS INSERT WERE REVISED TO ANOTHER SIZE 3 TS FEMORAL COMPONENT WITH STEM AND STEM EXTENDER, AUGMENTS, AND ANOTHER TS INSERT. REP PROVIDED IMPLANT SHEETS FROM CURRENT AND PREVIOUS REVISION, PRE-REVISION X-RAYS, AND REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Injury

  MAUDE report 8520623 ↗
• InjuryApr 16, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED. AS REPORTED BY THE REP: "THIS IS A REVISION TO A REVISION DONE ON (B)(6) 2016 [(B)(6) 2016 REVISION WAS OF COMPETITOR DEVICES]... THE CURRENT REVISION WAS DUE TO A SUSPECTED LOOSE FEMORAL COMPONENT, AS STATED BY SURGEON". A SIZE 4 TS FEMORAL COMPONENT WITH STEM AND AUGMENTS, AND A TS INSERT WERE REVISED TO ANOTHER SIZE 3 TS FEMORAL COMPONENT WITH STEM AND STEM EXTENDER, AUGMENTS, AND ANOTHER TS INSERT. REP PROVIDED IMPLANT SHEETS FROM CURRENT AND PREVIOUS REVISION, PRE-REVISION X-RAYS, AND REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Injury

  MAUDE report 8520308 ↗
• InjuryJun 29, 2018Mechanical Problem; Loss of Osseointegration; Mechanical Problem; Loss of Osseointegration

  AS REPORTED: "THIS IS A STUDY SUBJECT ON THE STRYKER SPONSORED STUDY TRIATHLON TS REVISION STUDY. THE STUDY COORDINATOR SENT IN AN ADVERSE EVENT FORM NOTING THAT THE SUBJECT EXPERIENCED FEMORAL AND TIBIAL COMPONENT LOOSENING AND UNDERWENT A REVISION ON (B)(6) 2018."

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 7652526 ↗
• InjuryJun 29, 2018Mechanical Problem; Loss of Osseointegration; Mechanical Problem; Loss of Osseointegration

  AS REPORTED: "THIS IS A STUDY SUBJECT ON THE (B)(6) STUDY. THE STUDY COORDINATOR SENT IN AN ADVERSE EVENT FORM NOTING THAT THE SUBJECT EXPERIENCED FEMORAL AND TIBIAL COMPONENT LOOSENING AND UNDERWENT A REVISION ON (B)(6) 2018".

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 7652450 ↗