Triathlon 5512-F-502Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327026634), received between Sep 10, 2019 and Jan 16, 2026 — 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.

• InjuryJan 16, 2026Unstable

  UPDATE: UPDATE ON (b)(6)2026 BASED ON MEDICAL REVIEW: ""[...]" TIBIA WITH LOOSENING SEEN AROUND THE TIBIAL STEM. IMPLANT HAS FALLEN INTO VARUS, AND THE MEDIAL PLATEAU IS COLLAPSED. THE TIBIAL STEM IS IMPINGING ON THE LATERAL CORTEX. FEMORAL COMPONENT NOT CLEARLY LOOSE BUT IN SIGNIFICANT EXTENSION ON THE LATERAL VIEW. "[...]"

  Patient problems: Inadequate Osseointegration; Joint Laxity; Pain; Periprosthetic fracture

  MAUDE report 24097107 ↗
• InjuryJun 16, 2022Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED. AS REPORTED BY REP: "PT. PRESENTED WITH THIGH PAIN, IMAGING WAS INDICATIVE OF A LOOSE FEMORAL IMPLANT FOLLOWING A KNEE-REVISION "BACK IN (B)(6) OF 2017". SURGEON RULED OUT INFECTION AND DETERMINED THE FEMORAL CONSTRUCT WAS ASEPTICALLY LOOSE. HE PERFORMED A REVISION OF THE FEMORAL IMPLANTS, LEAVING THE TIBIAL BASEPLATE AND STEM IN-SITU. NO FURTHER INFORMATION AVAILABLE." SPOKE TO REP. NO WEAR OR DAMAGE WAS NOTED INTRA-OPERATIVELY.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 14723096 ↗
• InjuryJun 15, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO LOOSENING. REVISING SURGEON REPORTED THAT CAUSE OR CONTRIBUTOR TO LOOSENING WAS DUE TO THE PRIOR SURGEON NOT USING ENOUGH CEMENT. THE PATIENT'S ENTIRE KNEE CONSTRUCT WAS REVISED. REP PROVIDED EXPLANT PICTURES AND REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Injury

  MAUDE report 10152174 ↗
• InjurySep 24, 2019Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO PROGRESSIVE RADIOLUCENCY AROUND THE TIBIAL AND FEMORAL STEMS. A KNEE CONSTRUCT WITH TIBIAL BASEPLATE AND STEM, FEMORAL COMPONENT AND STEM, AND A CS INSERT WERE REVISED TO A TS CONSTRUCT. REP PROVIDED A WEBOPS REPORT, AN EXCERPT FROM AN OPERATIVE REPORT, EXPLANT PICTURES AND X-RAYS FROM (B)(6) 2019 AND REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 9109427 ↗
• InjurySep 10, 2019Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO PAIN AND LOSS OF FUNCTION. INTRA-OPERATIVELY, THE FOLLOWING WAS NOTED: THE SIZE 5 CEMENTED FEMORAL COMPONENT WAS LOOSE; THERE WAS A FRACTURE AT THE JUNCTION OF THE FEMORAL STEM AND 12X100 STEM; THE CEMENTED TIBIAL COMPONENT WAS LOOSE; THE JUNCTION OF THE STEM EXTENDER AND 12X50 STEM ON THE TIBIAL SIDE WAS LOOSE. THE PATIENT'S ENTIRE TS KNEE CONSTRUCT (INCLUDING FIVE AUGMENTS) WAS REVISED TO A TRIATHLON TS KNEE CONSTRUCT WITH A CONE. REP PROVIDED ONE PAGE OF THE PRIMARY OPERATIVE REPORT, AND REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration; Injury; Pain

  MAUDE report 8981540 ↗