Triathlon 5560-S-215Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613327026696), received between Oct 16, 2018 and Aug 18, 2026 — classified as 8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryAug 18, 2026Loss of Osseointegration

  It was reported that the patient's left knee was revised due to the following: Loosening of the femoral stem and breakage of the femoral stem where it threads into the femoral component, loosening of the tibial stem which was also broken. The TS knee was removed and another TS knee implanted with a revision baseplate, stems and cones. Rep can provide images, otherwise confirmed that no further information will be released by the hospital or surgeon.

  Patient problems: Inadequate Osseointegration

  MAUDE report 50308145 ↗
• InjuryAug 18, 2026Fracture

  It was reported that the patient's left knee was revised due to the following: Loosening of the femoral stem and breakage of the femoral stem where it threads into the femoral component, loosening of the tibial stem which was also broken. The TS knee was removed and another TS knee implanted with a revision baseplate, stems and cones. Rep can provide images, otherwise confirmed that no further information will be released by the hospital or surgeon.

  Patient problems: Inadequate Osseointegration

  MAUDE report 50303254 ↗
• InjuryFeb 25, 2026Loss of Osseointegration; Detachment of Device or Device Component

  THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO THE STEM BECOMING LOOSE/ UNTHREADING FROM THE FEMORAL COMPONENT (REP CONFIRMED THREADS/ IMPLANTS WERE NOT BROKEN). THE FEMORAL COMPONENT, STEM, AND LINER WERE REVISED. REP CONFIRMED THAT THERE WERE NO ALLEGATIONS AGAINST THE REVISED LINER, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration; Insufficient Information

  MAUDE report 24443727 ↗
• InjuryJan 14, 2024Loss of Osseointegration; Loss of Osseointegration

  DR. REVISED A RIGHT TRIATHLON TS TO A NEW TS DUE TO PATIENT COMPLAINING OF PAIN. BOTH FEMUR AND TIBIA WERE LOOSE.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 18509836 ↗
• InjuryNov 29, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  "THE SURGEON HAS SENT ME X RAY OF POST OP BILATERAL KNEE USING TS SYSTEM..... LATER ON POST OP THE TIBIA WAS BROKEN DISTALLY AT THE PROXIMAL PART OF THE STEM, AS PER THE PROVIDED X-RAY AND HE HAD TO TAKE THE PATIENT AGAIN TO OR TO MANIPULATE TRAUMA WITH CABLES AND BLADES".

  Patient problems: Bone Fracture(s)

  MAUDE report 15882061 ↗
• InjuryFeb 24, 2021Fracture; Fracture

  PATIENT NOW PRESENTS WITH A FRACTURE OF THE FEMORAL STEM AT THE JUNCTION OF THE BODY AND REQUIRES EXCHANGE OF FEMORAL AND HINGE COMPONENTS ON (B)(6) 2020.

  Patient problems: Insufficient Information

  MAUDE report 11374426 ↗
• InjuryOct 16, 2018Osseointegration Problem; Osseointegration Problem

  AS REPORTED: INDEX AND REVISION SURGEON (B)(6). "PROCEDURE: THE PATIENT HAD A COMPLEX HISTORY REGARDING HIS LEFT KNEE. HAD AN INDEX TKA OUT OF CORS SCOPE, THEN HE HAD A NEUROLOGICAL DIAGNOSIS THAT LED TO INSTABILITY DUE TO HYPEREXTENSION. HE HAD LEFT KNEE REVISIONS ON (B)(6) 2017. ALL COMPONENTS EXCHANGED. NOW IT WAS NOTED THAT THE FEMORAL COMPONENT WAS LOOSE AND UNDERWENT SECOND LEFT KNEE REVISION ON (B)(6) 2018. LONGER STEM AND CONE EXCHANGED, PATELLAR COMPONENT RETAINED. SOME COMPONENTS IN THE SECOND REVISION ARE OFF-LABEL USE".

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 7971088 ↗
• InjuryOct 16, 2018Osseointegration Problem; Osseointegration Problem

  AS REPORTED: "PROCEDURE: THE PATIENT HAD A COMPLEX HISTORY REGARDING HIS LEFT KNEE. HAD AN INDEX TKA OUT OF CORS SCOPE, THEN HE HAD A NEUROLOGICAL DIAGNOSIS THAT LED TO INSTABILITY DUE TO HYPEREXTENSION. HE HAD LEFT KNEE REVISIONS ON (B)(6) 2017. ALL COMPONENTS EXCHANGED. NOW IT WAS NOTED THAT THE FEMORAL COMPONENT WAS LOOSE AND UNDERWENT SECOND LEFT KNEE REVISION ON (B)(6) 2018. LONGER STEM AND CONE EXCHANGED, PATELLAR COMPONENT RETAINED. SOME COMPONENTS IN THE SECOND REVISION ARE OFF-LABEL USE".

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 7971075 ↗