Triathlon 5516-F-402Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327040821), received between May 21, 2019 and Nov 15, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 15, 2024Unstable; Loss of Osseointegration; Malposition of Device; Unstable; Loss of Osseointegration; Malposition of Device

  IN PROVIDING ADDITIONAL INFORMATION FOR ANOTHER EVENT (REVISION OF PATIENT'S RIGHT KNEE ON (B)(6)2024), REP PROVIDED AN OPERATIVE REPORT AND USAGE SHEET FOR A REVISION OF THE PATIENT'S RIGHT KNEE ON (B)(6)2024. PER OP REPORT: "ASEPTIC LOOSENING OF RIGHT KNEE FEMORAL COMPONENT CEMENTLESS WITH MILD VALGUS POSITION AND MILD INSTABILITY." THE FEMORAL COMPONENT AND INSERT WERE REVISED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20693296 ↗
• InjuryJan 30, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  PROCEDURE: THE PATIENT UNDERWENT RIGHT TOTAL KNEE REPLACEMENT (B)(6) 2019. PATIENT HAD PERIPROSTHETIC FEMUR FRACTURE RIGHT KNEE. THEN PATIENT UNDERWENT REVISION WITH ALL COMPONENTS EXCHANGED EXCEPT PATELLA ON (B)(6) 2019.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 9648912 ↗
• InjuryJan 17, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "THE PATIENT('S RIGHT KNEE) WAS REVISED DUE TO A METAL ALLERGY ACCORDING TO THE SURGEON. REVISION COMPONENTS INCLUDED WERE COMPETITOR DEVICES, AS WELL AS STRYKER CONES. COMPONENTS REMOVED WERE THE FEMUR, INSERT, TIBIAL COMPONENT. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Injury

  MAUDE report 9603208 ↗
• InjuryMay 21, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO A FEMORAL PERIPROSTHETIC FRACTURE SUSTAINED WHEN THE PATIENT FELL OUT OF BED. A SIZE 4 PS FEMORAL COMPONENT AND INSERT WERE REVISED TO A TS FEMUR AND INSERT WITH CABLES. REP PROVIDED PRE- AND POST-OP X-RAYS AND A PRIMARY IMPLANT REPORT AND REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Bone Fracture(s); Fall; Injury

  MAUDE report 8627510 ↗