Triathlon 5515-F-501Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07613327050394), received between Jun 22, 2017 and Jun 19, 2023 — classified as 12 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of Osseointegration” (4 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJun 19, 2023Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED. AS REPORTED: "THE REVISION TODAY WAS SECONDARY TO INFECTION AND FEMORAL LOOSENING." A PS FEMORAL COMPONENT AND TS INSERT WERE REVISED TO A TS FEMORAL COMPONENT WITH STEM AND AUGMENTS AND ANOTHER TS INSERT. THE STEMMED TIBIAL BASEPLATE REMAINED IN SITU.

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 17149892 ↗
• InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT PRIMARY LEFT TKA ON (B)(6) 2017. PATIENT FELL AND HAD A PERIPROSTHETIC FRACTURE (B2) OF THE DISTAL FEMUR. WAS REVISED ON (B)(6), 2022. ALL COMPONENTS EXCHANGED EXCEPT PATELLA.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 15967078 ↗
• InjuryMay 30, 2022Loss of Osseointegration; Malposition of Device; Loss of Osseointegration; Malposition of Device

  REVISION OF PS FEMUR TO TS FEMUR WITH AUGMENTS. FEMORAL COMPONENT HAD CHANGED ALIGNMENT SINCE ORIGINAL SURGERY IN (B)(6) 2021 AND IS NOW IN 10DEG VALGUS ACCORDING TO PRECISION NAVIGATION. ON X-RAY THE SURGEON STATED THE ALIGNMENT NOW LOOK VALGUS. TIBIAL COMPONENTS NOT REVISED. TS LINER IMPLANTED. LEFT SIDE.

  Patient problems: Ambulation or Postural Difficulties; Inadequate Osseointegration

  MAUDE report 14540110 ↗
• InjuryJul 20, 2021Loss of Osseointegration; Loss of Osseointegration

  AS REPORTED: "LEFT KNEE REVISION FOR LOOSE FEMUR." A SIZE 5 PS FEMORAL COMPONENT AND 5X11 PS INSERT WERE REVISED TO A SIZE 5 TS FEMORAL COMPONENT AND 5X14 PS INSERT WITH A FEMORAL STEM AND AUGMENTS. SPOKE TO REP: THE STEM PLACED AT THE PRIMARY SURGERY WAS ON THE TIBIAL SIDE. THERE ARE NO ALLEGATIONS AGAINST THE REVISED LINER. REP IS NOT AWARE OF ANY CAUSE OR CONTRIBUTOR FOR THE LOOSENING. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12195055 ↗
• InjuryApr 26, 2021Unstable; Unstable

  PATIENT WOULD LIKE TO KNOW IF HER IMPLANT ARE PART OF A RECALL. PATIENT IS ASYMPTOMATIC. UPDATED ON 01APR2021 BASED ON MEDICAL REVIEW: "[...] UNTIL (B)(6) 2020 [...] ON THE LEFT THE ROM WAS 0-90°, ALSO WITH 1MM OPENING TO VARUS STRESS AND STABLE TO VALGUS STRESS. THERE WAS A MILD INFUSION AND GOOD STRENGTH. [...] "

  Patient problems: Joint Laxity; Loss of Range of Motion; Pain

  MAUDE report 11724599 ↗
• InjuryAug 31, 2020Unstable; Unstable

  PROCEDURE: THE PATIENT UNDERWENT LEFT AND RIGHT TOTAL KNEE REPLACEMENT (B)(6) 2016. PATIENT UNDERWENT REVISION LEFT TOTAL KNEE ARTHROPLASTY DUE TO INSTABILITY. ALL COMPONENTS EXCHANGED, EXCEPT PATELLA ON (B)(6) 2020.

  Patient problems: Injury

  MAUDE report 10471809 ↗
• InjurySep 17, 2019Unstable; Unstable

  DR REVISED A TOTAL LEFT KNEE DONE BY DR IN (B)(6) 2017 DUE TO FLEXION INSTABILITY.

  Patient problems: Injury

  MAUDE report 9079591 ↗
• InjuryMay 8, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  TRIATHLON PS WAS REVISED DUE TO STIFFNESS AND PATIENT COMPLAINING OF NOT BEING ABLE TO FLEX GREATER THAN 100DEG. ORIGINAL SURGERY DATE (B)(6) 2017. ALL COMPONENTS REMOVED, EXCEPT PATELLA, AND REPLACED WITH TRIATHLON TS.

  Patient problems: Injury; Loss of Range of Motion

  MAUDE report 8592855 ↗
• InjuryMar 12, 2019Loss of Osseointegration; Loss of Osseointegration

  PATIENT HAD HAD A PRIMARY TOTAL KNEE APPROXIMATELY 3 YEARS AGO AT ANOTHER HOSPITAL. ORIGINAL SURGEON USED A UNIVERSAL BASEPLATE AND A TS INSERT.. HE USED A PRIMARY PS FEMUR. THE FEMORAL COMPONENT LOOSENED. IT WAS REMOVED AND REPLACED WITH A TS FEMORAL COMPONENT. SURGEON ALLEGES NO DEFECTS OF THE COMPONENTS AND SUGGESTED PATIENT FACTORS MAY HAVE CONTRIBUTED TO THE LOOSENING.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8412778 ↗
• InjuryOct 17, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT REPORTEDLY PRESENTED WITH PAIN AND THERE IS A DELAYED UNION OF PERIPROSTHETIC FRACTURE AND THE ORIF PLATE IS FRACTURED SO THE PATIENT UNDERWENT LEFT DISTAL FEMORAL REVISION HINGE SURGERY ON (B)(6) 2018. ALL COMPONENTS EXCHANGED EXCEPT PATELLA".

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

  MAUDE report 7976576 ↗
• InjuryOct 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT PRIMARY LEFT TOTAL KNEE ARTHROPLASTY (B)(6) 2017. PATIENT WAS NOTED DISTAL LEFT FEMUR PP FRACTURE (TYPE D) AT THE PROXIMAL EDGE OF THE WELL-FIXED FEMORAL COMPONENT. ON (B)(6) 2017 A ORIF WAS PERFORMED WITH A FEMUR PLATE, AND CABLES".

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 7971390 ↗
• InjuryOct 13, 2017Break; Crack; Material Distortion; Packaging Problem; Break; Crack; Material Distortion; Packaging Problem

  THE CUSTOMER REPORTED THAT WHEN THE PACKAGE WAS OPENED IN THEATRE, ONE OF THE INNER LAYERS WAS CRACKED. THE OUTER LAYER LOOKED UNDAMAGED AND THE STERILE INNER LAYER WAS INTACT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6947805 ↗
• MalfunctionJun 22, 2017Packaging Problem; Break; Device Damaged Prior to Use; Packaging Problem

  THE CUSTOMER REPORTED THAT THEY OPENED A TRIATHLON FEMUR (5515-F-501 / BEP2D) AND THE INNER PLASTIC WAS BROKEN SO THEY COULD NOT USE IT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 6661442 ↗