Triathlon 5537-G-616Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613327027419), received between Feb 16, 2018 and Aug 21, 2024 — classified as 8 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryAug 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT WAS DIAGNOSED WITH ARTHROFIBROSIS. AN MUA WAS PERFORMED ON (B)(6) 2017. THE EVENT WAS CONSIDERED RESOLVED ON 02AUG2017.

  Patient problems: Fibrosis

  MAUDE report 20019970 ↗
• InjuryDec 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "REVISION TODAY WAS DUE TO COMPLAINT OF PAIN AND OBSERVATION OF LUCENCY AROUND THE TIBIAL CEMENT MANTLE." PATIENT'S LEFT KNEE WAS REVISED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 13049154 ↗
• InjuryNov 17, 2021Fracture; Fracture

  AS REPORTED: "THE SPINE ON THE SIZE 6X16MM TS INSERT SHEARED OFF AND BECAME WEDGED IN FEMORAL NOTCH. NO MEDICAL OR OPERATIVE RECORDS AVAILABLE. THE PRIMARY KNEE WAS DONE IN ANOTHER HOSPITAL IN 2007." SPOKE TO REP: NO TRAUMA WAS REPORTED TO THE REP. CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED ARE THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 12829482 ↗
• InjurySep 18, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED FOR PAIN. THOUGH THE SURGEON REPORTED ALL COMPONENTS AS WELL POSITIONED, THE ENTIRE KNEE CONSTRUCT WAS REVISED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED.

  Patient problems: Implant Pain; Pain

  MAUDE report 10554157 ↗
• InjuryApr 17, 2020Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO INSTABILITY. POSSIBLE CAUSE OR CONTRIBUTOR FOR INSTABILITY NOT REPORTED TO REP. THE PATIENT'S FEMORAL SIDE AND TIBIAL INSERT WERE REVISED. REP PROVIDED USAGE SHEET FROM CURRENT AND PREVIOUS SURGERIES, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Injury

  MAUDE report 9973728 ↗
• InjuryJul 25, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "FAILED EXTENSOR MECHANISM ALLOGRAFT S/P REVISION RIGHT TOTAL KNEE ARTHROPLASTY."

  Patient problems: Injury

  MAUDE report 8827729 ↗
• InjuryMar 25, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "THIS IS A STUDY PATIENT ON THE TRIATHLON TS REVISION OUTCOMES STUDY. THE PATIENT WAS SEEN BY HIS DOCTOR ON (B)(6) 2018 COMPLAINING OF EXCESSIVE RIGHT KNEE PAIN WHICH HAS BEEN INCREASING FOR ABOUT A YEAR. THE CLINIC NOTES DOCUMENT THAT THIS PAIN MAY BE RELATED TO PATELLAR CLUNK SYNDROME AND MILD GLOBAL LAXITY. ON THE ADVERSE EVENT REPORT SUBMITTED TO STRYKER IT WAS NOTED THAT THE RELATIONSHIP TO THE DEVICE WAS UNCERTAIN". PATIENT WAS NOT REVISED AS OF THE EVENT DATE.

  Patient problems: Injury; Pain

  MAUDE report 8449234 ↗
• InjuryFeb 16, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE SURGEON REPORTED THAT THE TRIATHLON TS 19MM INSERT WOULDN¿T SIT CORRECTLY IN UNIVERSAL BASE PLATE. HE FURTHER REPORTED THAT HE THEN INSERTED THE TS 16MM INSERT INTO THE UNIVERSAL TIBIAL BASE PLATE, AGAIN THIS DIDN¿T SEAT PROPERLY, HE IMPACTED THE LINER AGAIN AND INSERTED THE POST AND SAID THAT HE WOULD BRING PATIENT BACK TO THEATRE NEXT DAY FOR A LINER EXCHANGE. THERE WAS A 10 MINUTE DELAY TO SURGERY.

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

  MAUDE report 7277372 ↗