Triathlon 5536-B-700Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327041521), received between Jul 27, 2018 and Feb 14, 2024 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (1 report).

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

• MalfunctionFeb 14, 2024Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  PRIMARY PROCEDURE, LEFT KNEE. IT WAS REPORTED THAT THE INSERT WAS NOT SEATING POSTERIORLY. INSERT WAS WASTED AND A SECOND INSERT OBTAINED. THIS INSERT WAS ALSO NOT SEATING POSTERIORLY. THE INSERT HAD TO BE HELD IN PLACE AND GENTLY MALLETED IN. PROCEDURE COMPLETED SUCCESSFULLY WITH A DELAY OF LESS THAN ONE MINUTE. TOURNIQUET WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18708111 ↗
• InjuryMay 14, 2022Migration; Migration

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO TIBIAL SUBSIDENCE. THE TIBIAL BASEPLATE AND INSERT WERE REVISED. REP CONFIRMED THAT THERE WERE NO ALLEGATIONS AGAINST THE REVISED INSERT, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 14403150 ↗
• InjuryFeb 2, 2021Loss of Osseointegration; Loss of Osseointegration

  IT'S ALLEGED BY THE ATTORNEY, THROUGH THE FILING OF A LEGAL CLAIM, THAT THE CLAIMANT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2017 DUE TO OSTEOARTHRITIS WHERE HE WAS IMPLANTED WITH A STRYKER KNEE SYSTEM. IT IS FURTHER ALLEGED THAT THE CLAIMANT UNDERWENT REVISION OF THE TIBIAL COMPONENT ON (B)(6) 2019 DUE TO LOOSENING.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11269280 ↗
• InjuryJul 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH A MEDWATCH " SEVERE LEFT KNEE ACUTE PERIPROSTHETIC INFECTION. TIBIAL COMPONENT NOTED TO BE LOOSE AT THE TIME OF DEBRIDEMENT. LEFT KNEE ARTHROTOMY WITH COMPLETE EXCISIONAL DEBRIDEMENT AND SYNOVECTOMY PERFORMED. ALSO PERFORMED WAS EXCISION OF ANY INFECTED DISTAL FEMORAL AND PROXIMAL TIBIAL BONE. WAS ABLE TO OBTAIN A CLEAN JOINT FOLLOWING DEBRIDEMENT AND THOROUGH IRRIGATION. PRIOR TO RE-IMPLANTATION, ALL DIRTY INSTRUMENTS AND DRAPES WERE REMOVED. THE PATIENT WAS THEN REPREPPED AND REDRAPED WITH NEW INSTRUMENTS OPEN PRIOR TO TIBIAL COMPONENT REVISION."

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8804433 ↗
• InjuryJul 27, 2018Unstable; Unstable

  IT WAS REPORTED THAT PATIENT'S LEFT KNEE WAS REVISED DUE TO INSTABILITY AND PAIN.

  Patient problems: Injury; Pain

  MAUDE report 7726459 ↗