Triathlon 5512-F-202Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327026801), received between Jul 23, 2019 and Mar 4, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (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.

• InjuryMar 4, 2026Degraded; Material Erosion; Detachment of Device or Device Component

  THE FOLLOWING INFORMATION WAS PROVIDED: THE CUSTOMER REPORTED THAT: "FRACTURE OF THE TIBIAL AND FEMORAL STEMS LESS THAN TWO YEARS AFTER PROSTHESIS PLACEMENT. DURING REVISION SURGERY, FRACTURE OF THE IMPLANTS AND VERY SIGNIFICANT METALLOSIS WITHIN THE KNEE WERE OBSERVED. IMPLANTATION DATE: (B)(6) 2024; DATE OF EXPLANTATION: (B)(6) 2026."

  Patient problems: Ambulation or Postural Difficulties; Foreign Body Reaction; Metal Related Pathology; Osteolysis

  MAUDE report 24505309 ↗
• InjuryNov 14, 2023Malposition of Device; Adverse Event Without Identified Device or Use Problem; Malposition of Device; Adverse Event Without Identified Device or Use Problem

  REAMER CONTACTED WITH BONE PIN WHICH WAS PLACED IN TIBIA. IMPLANT WAS INSERTED. BUT IMPLANTS WHICH WERE PLACED IN TIBIA AND FEMUR WERE REMOVED DURING CURING OF CEMENT BECAUSE THESE IMPLANTS PLACED INTERNAL ROTATION. AT THAT TIME, POSTERIOR THIGH BONE AND ANTERIOR TIBIA WERE FRACTURED. ADDITIONAL INFORMATION: THE REAMER AND PIN CONTACTED, CAUSING IT TO REAM TOWARD A PLACE IT WASN'T SUPPOSED TO BE WHICH CAUSED THE INTERNAL ROTATION. X-RAY SHOWS THERE WAS NO FRACTURE LOCATED AT THE TIBIAL BONE PIN SITE.

  Patient problems: Bone Fracture(s)

  MAUDE report 18130451 ↗
• InjuryAug 17, 2021Loss of Osseointegration; Loss of Osseointegration

  AS REPORTED: "PATIENT IS A 57-YEAR-OLD FEMALE WHO PREVIOUSLY UNDERWENT RIGHT TOTAL KNEE REPLACEMENT - OUTSIDE CORS SCOPE (ROI IN 2016). SHE UNDERWENT REVISION FOR TIBIAL COMPONENT LOOSENING (B)(6) 2017, ALL COMPONENTS REVISED. PATIENT REQUIRED A SECOND REVISION DUE TO ASEPTIC LOOSENING OF FEMORAL COMPONENT PERFORMED IN (B)(6) 2020. ALL COMPONENTS WHERE EXCHANGED." AN OP REPORT WAS PROVIDED WHICH CITED ASEPTIC LOOSENING OF THE TIBIA, AND "AROUND THE FEMUR, THERE WAS ALSO EXTENSIVE AMOUNT OF BONE LOSS AND THE FEMUR APPEARED TO BE ALSO LOOSE. WE THEREFORE DECIDED TO REMOVE BOTH COMPONENTS..."

  Patient problems: Inadequate Osseointegration; Inflammation

  MAUDE report 12334639 ↗
• InjuryJul 23, 2019Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO STEM LOOSENING. AS A RESULT, THE STEM WAS BUTTRESSING AGAINST THE CORTEX. THE FEMORAL COMPONENT, STEM AND LINER WERE REVISED. REP REPORTED HE MAY BE ABLE TO OBTAIN X-RAYS AND OPERATIVE REPORT, AND REPORTED THAT NO FURTHER INFORMATION WOULD BE AVAILABLE.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8816447 ↗
• InjuryJul 23, 2019Osseointegration Problem; Insufficient Device Problem Information; Osseointegration Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED. REASON FOR REVISION UNKNOWN AT THE TIME OF REPORT. A FEMORAL COMPONENT WAS REVISED. UPDATE (B)(6) 2019 GG: IT WAS STATED "17X100 FLUTED STEM WAS USED ON THE FEMUR. THE REASON FOR THE REVISION WAS FEMORAL COMPONENT LOOSENING WHICH CAUSED THE STEM TO PISTON AGAINST THE CORTEX".

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8816446 ↗