Triathlon 5543-A-400Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327014686), received between Jun 29, 2018 and Apr 8, 2021 — classified as 4 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 8, 2021Loss of Osseointegration; Loss of Osseointegration

  PATIENTS REVISION KNEE WAS REVISED FOR FEMORAL LOOSENING.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11634189 ↗
• 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 8520309 ↗
• InjuryFeb 4, 2019Component Missing; Component Missing

  RIGHT KNEE, REVISION OF COMPETITOR DEVICES. IT WAS REPORTED THAT THE SURGICAL PLAN WAS TO IMPLANT TWO 5MM AUGMENTS. AT THE TIME OF SURGERY, 1 OF THE AUGMENTS WAS FOUND TO HAVE BEEN RETURNED TO THE BRANCH. THE REP CALLED THE BRANCH TO URGENTLY RETURN THE DEVICE, SURGEON DECIDED TO FILL THE GAP WITH CEMENT. A SURGICAL DELAY OF 12 MINUTES WAS REPORTED, WITH USE OF TOURNIQUET UNKNOWN. SURGEON IS SATISFIED WITH THE RESULT AND HAS NO PLANS TO REVISE. REP REPORTED THAT X-RAYS, MEDICAL RECORDS, AND ADDITIONAL INFORMATION ARE NOT AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8302355 ↗
• 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 7652448 ↗