Triathlon 5512-F-301Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327026627), received between Jul 25, 2019 and May 1, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMay 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO NEW INFORMATION.

  Patient problems: Bone Fracture(s)

  MAUDE report 21941008 ↗
• InjuryJan 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS PER OP REPORT, "DURING OUR FEMORAL PREPARATION, WE HAD A SMALL HAIRLINE FRACTURE OF THE LATERAL CONDYLE, WHICH WAS FIXED WITH TWO HEADLESS HERBERT SCREWS SIZE 30MM AND SIZE 36MM, 4.5 CANNULATED HEADLESS SCREWS." IT WAS ALSO NOTED IN THE RELATED PI, THAT THE SURGEON IMPLANTED CEMENTLESS STEMS IN A CEMENT MANTLE. "THE SURGEON HAS SENT ME X RAY OF POST OP BILATERAL KNEE USING TS SYSTEM AND HE WAS WONDERING ABOUT THE DIFFERENCE BETWEEN STEMS IN BOTH KNEES AS IT LOOKS DIFFERENT DISTALLY. I INFORMED HIM THAT, ONE IS CEMENTED AND THE OTHER ONE IS CEMENTLESS. THEN, HE CLAIMED THAT COMPANY REP. WHO ATTENDED THE CASE OFFERED HIM ALL STEMS AS CEMENTED 15/100 FOR BOTH SIDES FEMUR AND TIBIA AND HE DID NOT LET HIM KNOW ABOUT CEMENTLESS FLUTED STEM, CONSEQUENTLY, HE APPLIED CEMENT MANTLE TO CEMENTLESS STEM"

  Patient problems: Bone Fracture(s)

  MAUDE report 16241208 ↗
• InjuryJul 21, 2021Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO ASEPTIC LOOSENING OF THE FEMORAL AND TIBIAL IMPLANTS. THE PATIENT'S KNEE WAS REVISED TO A GMRS KNEE. REVISING SURGEON REPORTED THE INDEX SURGEON DID NOT USE ENOUGH CEMENT ON THE ORIGINAL IMPLANTS. REP CONFIRMED THAT THERE ARE NO ALLEGATIONS AGAINST THE REVISED LINER. REP ALSO PROVIDED EXPLANT PICTURES AND REVISION USAGE, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12201361 ↗
• InjuryFeb 9, 2021Loss of Osseointegration; Loss of Osseointegration

  AS REPORTED: "LOOSE FEMORAL COMPONENT. NO OTHER INFORMATION IS AVAILABLE PER HOSPITAL POLICY." A LEFT FEMORAL COMPONENT, AUGMENTS, AND 16X100 STEM WERE REVISED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11300663 ↗
• InjurySep 1, 2020Loss of Osseointegration; Loss of Osseointegration

  THIS PI IS FOR THE KNEE REVISION DUE TO LOOSENING AND IMPINGEMENT ON (B)(6) 2020. POSTOPERATIVE DIAGNOSIS: THE PATIENT HAD A HISTORY OF LEFT KNEE REPLACEMENT (OUTSIDE OF CORS SCOPE). PATIENT UNDERWENT KNEE REVISION FOR MECHANICAL PROBLEM (B)(6) 2017. THE PATELLA WAS RETAINED. THE PATIENT UNDERWENT LEFT KNEE REPLACEMENT REVISION OF FEMORAL COMPONENTS AND POLYETHYLENE (B)(6) 2019. REPORTED AS CORS PER 8200KNEE ((B)(4)). PATIENT WAS FAILED LEFT TOTAL KNEE ARTHROPLASTY SECONDARY TO LOOSENING AND IMPINGEMENT OF FEMORAL COMPONENT. PATIENT UNDERWENT NEW REVISION OF LEFT TOTAL KNEE ARTHROPLASTY (B)(6) 2020. FEMORAL COMPONENTS AND POLYETHYLENE WHERE EXCHANGED.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 10479494 ↗
• InjuryJul 25, 2019Unstable; Insufficient Device Problem Information; Unstable; Insufficient Device Problem Information

  POSTOPERATIVE DIAGNOSIS: THE PATIENT HAD A HISTORY OF LEFT KNEE REPLACEMENT (OUTSIDE OF CORS SCOPE). PATIENT UNDERWENT KNEE REVISION FOR MECHANICAL PROBLEM (B)(6) 2017. THE PATELLA WAS RETAINED. THE PATIENT UNDERWENT LEFT KNEE REPLACEMENT REVISION OF FEMORAL COMPONENTS AND POLYETHYLENE (B)(6) 2019.

  Patient problems: Injury; Joint Laxity

  MAUDE report 8825979 ↗