Triathlon 5536-B-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327041477), received between Apr 22, 2020 and Jul 31, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 31, 2026Loss of Osseointegration

  The following information was provided: Due to loosening following TKA, all implants were removed and a revision procedure was performed.

  Patient problems: Ambulation or Postural Difficulties; Inadequate Osseointegration

  MAUDE report 50101872 ↗
• InjuryJul 15, 2026Migration

  THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO TIBIAL SUBSIDENCE. THE BASEPLATE AND INSERT WERE REVISED TO A BASEPLATE WITH STEM AND INSERT. 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: Insufficient Information

  MAUDE report 25833605 ↗
• InjuryNov 12, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT HAD A RIGHT KNEE REVISION, SECONDARY TO TIBIAL LOOSENING. THE TIBIAL IMPLANT WAS REPLACED. NO FURTHER INFORMATION IS AVAILABLE FROM THE DOCTOR OR HOSPITAL. THE USE OF MAKO IN THE INDEX SURGERY WAS NOT THOUGHT TO HAVE CONTRIBUTED TO THIS COMPLICATION.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23535929 ↗
• InjuryApr 15, 2024Malposition of Device; Malposition of Device

  PATIENT REPORTED LEFT KNEE PAIN AND NOTED PRODUCT IS "TOO LARGE". PATIENT IS SCHEDULED FOR A REVISION ON MARCH 21ST. AS PER MEDICAL REVIEW: "THE ADDITIONAL RADIOGRAPHS CONFIRM THAT THE FEMORAL IMPLANT IS AT THE VERY LEAST HYPER FLEXED, OUT OF THE RANGE OF ACCEPTABILITY. IT MAY WELL BE OVERSIZED AS WELL WHICH CAN ONLY BE DETERMINED USING DIGITAL OR ACETATE TEMPLATES. THE TIBIAL IMPLANT IS ALSO HYPER FLEXED WITH SOME POSTERIOR OVERHANG."

  Patient problems: Pain

  MAUDE report 19111548 ↗
• InjuryMar 15, 2022Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO INSTABILITY. A TIBIAL BASEPLATE AND INSERT WERE REVISED.

  Patient problems: Joint Laxity

  MAUDE report 13772985 ↗
• InjuryApr 22, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO A TIBIAL PERIPROSTHETIC FRACTURE. SURGEON REPORTED PATIENT FACTORS OF POOR BONE QUALITY AND OSTEOPENIA. THE TIBIAL COMPONENT, INSERT AND THE WELL-FIXED FEMUR WERE REVISED TO A LARGER-SIZED TS CONSTRUCT WITH STEMS AND AUGMENTS. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED LINER, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Bone Fracture(s); Inadequate Osseointegration

  MAUDE report 9986654 ↗