Triathlon 5517-F-502Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 07613327040968), received between Oct 25, 2017 and Mar 24, 2026 — classified as 11 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Unstable” (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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryMar 24, 2026Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: FEMUR REVISION SURGEON WANTS FEMUR SENT IN TO BE LOOKED AT. RIGHT KNEE.

  Patient problems: Inadequate Osseointegration; Insufficient Information

  MAUDE report 24676568 ↗
• InjuryOct 29, 2025Unstable; Unstable

  RIGHT-KNEE REVISION, PATIENT PRESENTED WITH KNEE-INSTABILITY. TIBIA BASEPLATE AND PATELLAR COMPONENTS WERE LEFT IN-SITU. NO COMPLAINTS FILED AGAINST THE COMPONENTS THEMSELVES, NO FURTHER INFO AVAILABLE.

  Patient problems: Joint Laxity

  MAUDE report 23417719 ↗
• InjuryFeb 20, 2025Degraded; Fracture; Degraded; Fracture

  AS REPORTED BY LEGAL: "IT WAS REPORTED BY COUNSEL THAT CLAIMANT UNDERWENT RIGHT TKA (B)(6) 2015, WITH TRIATHLON KNEE SYSTEM AND WAS REVISED ON (B)(6) 2024 DUE TO FRACTURE OF THE FEMORAL COMPONENT AT THE MEDIAL FEMORAL CONDYLE AND THE TROCHLEA." REVISION OPERATIVE REPORT ALSO CITES METALLOSIS. THE PATIENT'S KNEE WAS CONVERTED TO A COMPETITOR CONSTRUCT.

  Patient problems: Ambulation or Postural Difficulties; Foreign Body Reaction; Metal Related Pathology

  MAUDE report 21425964 ↗
• InjuryDec 15, 2023Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INSTABILITY AND CHRONIC EFFUSIONS. A CR FEMUR AND CS INSERT WERE REVISED TO PS COMPONENTS, AND THE PATIENT'S NATIVE PATELLA WAS RESURFACED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity

  MAUDE report 18340829 ↗
• InjurySep 13, 2023Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED. AS REPORTED: "PATIENT WAS REVISED DUE TO LOOSE FEMUR. NO OTHER INFORMATION AVAILABLE DUE TO HOSPITAL POLICY." A CR FEMORAL COMPONENT AND INSERT WERE REVISED TO A TS FEMORAL COMPONENT WITH STEM AND AUGMENTS, AND A NEW INSERT. MAKO ROBOT WAS USED IN THE REVISION FOR BONE CUTS. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED INSERT. UPDATE 01-SEP-2023 MF: PER CLINICIAN REVIEW OF THE PROVIDED MEDICAL RECORDS, THE X-RAYS SHOW "A DISPLACED FRACTURE OF THE MEDIAL FEMORAL CONDYLE."

  Patient problems: Bone Fracture(s); Inadequate Osseointegration

  MAUDE report 17735300 ↗
• InjuryFeb 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PERI-PROSTHETIC FRACTURE, INSERT SWAP. PATIENT FELL AND CAME IN THROUGH EMERGENCY ROOM. *UPDATE ON 6-APR-2022 PER CLINICIAN REVIEW: "[...] THE SECOND SET OF AP AND LATERAL X-RAYS SHOW A COMMINUTED OBLIQUE DISTAL FEMORAL FRACTURE AROUND A TKA. THE IMPLANT LOG FROM 1/12/2022 REVEALS THE FRACTURE WAS RECONSTRUCTED WITH A FEMORAL NAIL. [...]"

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

  MAUDE report 13450980 ↗
• InjurySep 1, 2021Loss of Osseointegration; Loss of Osseointegration

  PATIENT REPORTED LOOSE FEELING. RECENT GASTRIC BYPASS SURGERY. LUCENCY ON X-RAY. REVISION OF PRESS FIT FEMORAL COMPONENT FOR LOOSENING. REVISED WITH TRIATHLON TS FEMUR/STEM.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12405499 ↗
• InjuryAug 3, 2021Unstable; Unstable

  AS REPORTED: "THE (RIGHT KNEE) REVISION WAS PERFORMED DUE TO FLEXION INSTABILITY. THERE IS NO FURTHER INFORMATION AVAILABLE." SPOKE TO REP, WHO PROVIDED THE PRIMARY MAKO AND REVISION USAGE SHEETS. THERE ARE NO ALLEGATIONS AGAINST ANY OF THE BONE CUTS OR IMPLANT POSITIONING. A CR FEMUR, CS INSERT, AND CEMENTED PATELLA WERE REVISED TO A PS FEMUR WITH AUGMENTS, A TS INSERT, AND ANOTHER CEMENTED PATELLA. REP RE-CONFIRMED NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity

  MAUDE report 12271593 ↗
• InjuryMar 23, 2020Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INSTABILITY. A 4X9 CS INSERT AND CR FEMUR WERE REVISED TO A 4X11 PS INSERT AND PS FEMUR.

  Patient problems: Injury

  MAUDE report 9866436 ↗
• InjuryJan 2, 2019Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT PATIENT'S RIGHT KNEE WAS REVISED DUE TO PAIN. REP PROVIDED PRIMARY OPERATIVE AND WEBOPS REPORT, VITALS, AND PRE-REVISION X-RAYS AND REPORTED THAT ADDITIONAL X-RAYS, MEDICAL RECORDS, AND FURTHER INFORMATION ARE NOT AVAILABLE DUE TO HOSPITAL POLICY. UPDATE BASED ON CLINICAL REVIEW FINDINGS AR 4DEC2018: COMPLEX MALALIGNMENT OF COMPONENTS INCLUDING AN OBLIQUE JOINT SPACE BETWEEN FEMUR AND TIBIA, LIKELY FEMORAL ROTATORY MALPOSITION AND PATELLOFEMORAL MALALIGNMENT WITH LATERAL TILT/SHIFT HAVE CONTRIBUTED TO AN OVERLOAD CONDITION IN THE PF JOINT RESULTING ULTIMATELY IN DISASSOCIATION BETWEEN PATELLAR METAL-BACKING AND POLY REQUIRING REVISION SURGERY.

  Patient problems: Injury; Pain

  MAUDE report 8209345 ↗
• InjuryAug 2, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S RIGHT KNEE WAS REVISED DUE TO MECHANICAL COMPLICATIONS. SURGEON WOULD NOT ELABORATE ON THE MECHANICAL COMPLICATIONS BUT EMPHATICALLY RULED OUT THE DEVICES HAVING CAUSED OR CONTRIBUTED TO THE COMPLICATIONS. PATIENT'S ENTIRE KNEE CONSTRUCT WAS REVISED TO A TRIATHLON TS CONSTRUCT. REP REPORTED THAT X-RAYS, MEDICAL RECORDS, AND FURTHER INFORMATION WILL NOT BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Injury

  MAUDE report 7742449 ↗
• MalfunctionMar 27, 2018Device Packaging Compromised; Device Packaging Compromised

  WHEN BOX WAS OPENED, THE OUTER BLISTER WAS BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7374391 ↗
• MalfunctionNov 22, 2017Packaging Problem; Packaging Problem

  A DISTRIBUTOR REPORTED THAT: "BEFORE THE SURGERY, WHEN PREPARING THE DEVICES, THE MEDICAL STAFF OBSERVED THAT THE PACKAGING WAS NOT DAMAGED BUT THE INNER PLASTIC SHELL IS BROKEN AT THE WELD. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY"

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7054581 ↗
• MalfunctionOct 25, 2017Device Contamination with Chemical or Other Material; Packaging Problem; Device Contamination with Chemical or Other Material; Packaging Problem

  IT WAS REPORTED THAT WHILE PERFORMING A PRIMARY IMPLANT PROCEDURE FOR PATIENT'S RIGHT KNEE, A PRESS FIT FEMORAL IMPLANT WAS UNPACKAGED. THE OUTER PACKAGING WAS REPORTED TO BE INTACT. THE INNER PLASTIC PACKAGING APPEARED PARTIALLY MELTED AND PART OF IT WAS STUCK TO THE IMPLANT. THE PLASTIC WAS DIFFICULT TO REMOVE AND LEFT A MARK ON THE IMPLANT. THE SURGEON REFUSED USE OF THE IMPLANT DUE TO STERILITY CONCERNS. THE PROCEDURE WAS ALTERED TO USE A CEMENTED IMPLANT WHICH WAS IMMEDIATELY AVAILABLE. REP REPORTED THAT THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6977139 ↗