Triathlon 5512-F-602Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327026658), received between Mar 11, 2019 and May 29, 2025 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 29, 2025Unstable; Unstable

  AS REPORTED: "REV RTKA FEMORAL REVISION FOR INSTABILITY, GOING IN WITH HINGE FEMUR." TIBIAL COMPONENTS AND PATELLAR COMPONENT WERE RETAINED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity

  MAUDE report 22108598 ↗
• InjuryJan 8, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED. PRE-OP DIAGNOSIS WAS FOR SUSPECTED LOOSENING OF THE TIBIAL BASEPLATE. A PRE-OP X-RAY ALSO REVEALED THAT THE BOTTOM NUB OF THE BASEPLATE HAD BECOME UNTHREADED FROM THE BASEPLATE. INTRA-OPERATIVELY, LOOSENING OF THE FEMORAL COMPONENT WAS ALSO NOTED. THE PATIENT'S KNEE CONSTRUCT WAS REVISED TO A TS KNEE WITH STEMS, CONES, AND AUGMENTS. THERE ARE NO ALLEGATIONS AGAINST THE REVISED INSERT.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 9566593 ↗
• InjuryAug 26, 2019Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO FEMORAL COMPONENT LOOSENING. THE PATIENT'S ENTIRE KNEE CONSTRUCT (FEMORAL COMPONENT, STEM, AUGMENTS, INSERT, TIBIAL BASEPLATE WITH STEM) WERE REVISED TO A DISTAL FEMORAL REPLACEMENT DUE TO THE PATIENT'S POOR BONE QUALITY. NO ALLEGATIONS AGAINST THE TIBIAL BASEPLATE OR LINER WERE REPORTED TO THE REP. REP REPORTED THAT THE HOSPITAL AND SURGEON WILL NOT RELEASE ANY FURTHER INFORMATION.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8930824 ↗
• InjuryMar 15, 2019Loss of Osseointegration; Insufficient Device Problem Information; Loss of Osseointegration; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "LOOSE IMPLANTS RIGHT TOTAL KNEE ARTHROPLASTY".

  Patient problems: Inadequate Osseointegration

  MAUDE report 8424666 ↗
• InjuryMar 11, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED AFTER PATIENT COMPLAINT OF PAIN. INTRA-OPERATIVELY, THE TIBIAL BASEPLATE WAS NOTED TO BE LOOSE, AND THE FEMORAL COMPONENT BROKEN AT THE COMPONENT/STEM INTERFACE. THE BASEPLATE, FEMORAL COMPONENT, STEM, AND INSERT WERE REVISED. THERE ARE NO ALLEGATIONS AGAINST THE LINER, AND THE PATIENT'S PATELLAR IMPLANT WAS NOT REVISED. PATIENT WAS REVISED TO A UNIVERSAL BASEPLATE, TS FEMORAL COMPONENT, 2 STEMS, 2 OFFSET ADAPTERS, 8 AUGMENTS, AND TS INSERT. REP WILL BE PROVIDING A PATIENT PACKET AND REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Injury; Pain

  MAUDE report 8407634 ↗