Triathlon 5543-A-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327014853), received between Aug 28, 2018 and Sep 10, 2019 — classified as 4 injuries.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO PAIN AND LOSS OF FUNCTION. INTRA-OPERATIVELY, THE FOLLOWING WAS NOTED: THE SIZE 5 CEMENTED FEMORAL COMPONENT WAS LOOSE; THERE WAS A FRACTURE AT THE JUNCTION OF THE FEMORAL STEM AND 12X100 STEM; THE CEMENTED TIBIAL COMPONENT WAS LOOSE; THE JUNCTION OF THE STEM EXTENDER AND 12X50 STEM ON THE TIBIAL SIDE WAS LOOSE. THE PATIENT'S ENTIRE TS KNEE CONSTRUCT (INCLUDING FIVE AUGMENTS) WAS REVISED TO A TRIATHLON TS KNEE CONSTRUCT WITH A CONE. REP PROVIDED ONE PAGE OF THE PRIMARY OPERATIVE REPORT, AND REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration; Injury; Pain

  MAUDE report 8981447 ↗
• InjurySep 10, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO PAIN AND LOSS OF FUNCTION. INTRA- OPERATIVELY, THE FOLLOWING WAS NOTED: THE SIZE 5 CEMENTED FEMORAL COMPONENT WAS LOOSE; THERE WAS A FRACTURE AT THE JUNCTION OF THE FEMORAL STEM AND 12X100 STEM; THE CEMENTED TIBIAL COMPONENT WAS LOOSE; THE JUNCTION OF THE STEM EXTENDER AND 12X50 STEM ON THE TIBIAL SIDE WAS LOOSE. THE PATIENT'S ENTIRE TS KNEE CONSTRUCT (INCLUDING FIVE AUGMENTS) WAS REVISED TO A TRIATHLON TS KNEE CONSTRUCT WITH A CONE. REP PROVIDED ONE PAGE OF THE PRIMARY OPERATIVE REPORT, AND REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration; Injury; Pain

  MAUDE report 8981444 ↗
• InjuryAug 28, 2018Mechanical Problem; Mechanical Problem

  AS REPORTED: "THIS SUBJECT IS A PARTICIPANT IN THE TRIATHLON TS OUTCOMES STUDY. AN ADVERSE EVENT FORM WAS RECEIVED ON (B)(6) 2018 NOTING THAT THIS SUBJECT HAD A REVISION OF THE FEMORAL COMPONENT ON (B)(6) 2016 DUE TO PROGRESSIVE LOOSENING OF THE FEMORAL COMPONENT. NO OTHER PREVIOUS ADVERSE EVENT FORMS HAD BEEN SUBMITTED. THE 2-YEAR FOLLOW-UP VISIT ON (B)(6) 2016 NOTED THAT THE SUBJECT WAS EXPERIENCING MODERATE PAIN".

  Patient problems: Injury; Pain

  MAUDE report 7823225 ↗
• InjuryAug 28, 2018Mechanical Problem; Mechanical Problem

  AS REPORTED: "THIS SUBJECT IS A PARTICIPANT IN THE TRIATHLON TS OUTCOMES STUDY. AN ADVERSE EVENT FORM WAS RECEIVED ON JULY 31, 2018 NOTING THAT THIS SUBJECT HAD A REVISION OF THE FEMORAL COMPONENT ON (B)(6) 2016 DUE TO PROGRESSIVE LOOSENING OF THE FEMORAL COMPONENT. NO OTHER PREVIOUS ADVERSE EVENT FORMS HAD BEEN SUBMITTED. THE 2-YEAR FOLLOW-UP VISIT ON (B)(6) 2016 NOTED THAT THE SUBJECT WAS EXPERIENCING MODERATE PAIN".

  Patient problems: Injury; Pain

  MAUDE report 7823055 ↗