Triathlon 5517-F-601Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07613327040975), received between Jul 27, 2017 and Mar 19, 2025 — classified as 11 injuries, 1 malfunction.

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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMar 19, 2025Mechanical Problem; Mechanical Problem

  REVISED A LEFT TOTAL KNEE ORIGINALLY DONE (B)(6) 2024 DUE TO PAIN/LIMITED RANGE OF MOTION. DR. HAD REVISED THE PATIENT ON (B)(6) 2024 FROM AN MCK MEDIAL UNI DONE ORIGINALLY ON (B)(6) 2023 (UNDER ANOTHER PI). WHEN THE FEMUR WAS REMOVED, DR. OBSERVED THERE WAS MOSTLY FIBROUS INGROWTH.

  Patient problems: Fibrosis; Loss of Range of Motion; Pain

  MAUDE report 21642869 ↗
• InjuryNov 21, 2023Loss of Osseointegration; Loss of Osseointegration

  PATIENT WOULD LIKE TO KNOW IF KNEE IMPLANTS ARE SUBJECT TO A RECALL. PATIENT NOTED LOOSENING. UPDATE PER CONVERSATION WITH PATIENT: PATIENT REPORTED AN ASPIRATION.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 18187244 ↗
• InjuryJan 24, 2022Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO PAIN AND FEMORAL LOOSENING. SURGEON REPORTED THAT A POSSIBLE CAUSE OR CONTRIBUTOR IS THAT THE ORIGINAL CUTS MADE WITH THE MAKO ROBOT SEEMED OFF. A CR FEMUR AND 7X9 CS INSERT WERE REVISED TO A TS FEMUR WITH STEM AND 7X9 PS INSERT. REP REPORTED THAT PICTURES CAN BE PROVIDED, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 13333172 ↗
• InjuryAug 11, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "DR. REVISED A LEFT KNEE DUE TO PATELLA INSTABILITY. THE TIBIA BASEPLATE WAS NOT REVISED. ALL OTHER COMPONENTS CAME OUT." A TRIATHLON CR FEMORAL COMPONENT, TRIATHLON CR X3 INSERT, AND TRITANIUM PATELLA WERE REVISED TO A TS FEMUR, PS INSERT, AND PATELLA WITH A STEM, CONES, AND AUGMENTS. PER REP: THERE ARE NO ALLEGATIONS AGAINST THE REVISED LINER OR THE ROBOT USED TO COMPLETE THE PRIMARY SURGERY.

  Patient problems: Joint Laxity

  MAUDE report 12310041 ↗
• InjuryMar 31, 2021Fracture; Unstable; Fracture; Unstable

  THE POSTERIOR MEDIAL ASPECT OF OUR CEMENTLESS TITANIUM KNEE REPLACEMENT BROKE OFF INSIDE THE PATIENT. THE ANTERIOR LOCKING WIRE ALSO FRAGMENTED INTO 3 PIECES, BUT THE POLY WAS STILL LOCKED AND ENGAGED INTO THE BROKEN TIBIA, AND NOT FRACTURED. PATIENT CAME IN WITH SWELLING, PAIN AND INSTABILITY, NOTICED ON XRAY, THEN CONFIRMED AND REVISED IN SURGERY. UPDATE: "THE REVISION WAS PERFORMED BECAUSE OF THE FRACTURE OF THE TIBIAL PLATE".

  Patient problems: Failure of Implant; Pain

  MAUDE report 11594862 ↗
• InjuryFeb 4, 2021Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO PAIN AND INSTABILITY. A CR FEMUR AND CS INSERT WERE REVISED TO A TS INSERT WITH AUGMENTS AND STEM, AND A PS INSERT. REP PROVIDED THE REVISION USAGE SHEET AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Pain

  MAUDE report 11282982 ↗
• InjuryDec 8, 2020Unstable; Loss of Osseointegration; Unstable; Loss of Osseointegration

  TRIATHLON TRITANIUM IMPLANTED AT INITIAL SURGERY. INSTABILITY LED TO FEMORAL AND INSERT EXCHANGE.

  Patient problems: Inadequate Osseointegration; Joint Laxity

  MAUDE report 10964782 ↗
• InjuryAug 6, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED: "...DURING THE LEFT TOTAL KNEE REPLACEMENT A CRUCIATE RETAINING FEMUR WAS MISTAKENLY OPENED AND IMPLANTED INSTEAD OF A POSTERIOR STABILIZED FEMUR. THIS MISTAKE WENT UNNOTICED UNTIL THE PATIENT WAS IN POST-OP RECOVERY. THE PATIENT WAS THEN RETURNED TO THE OPERATING ROOM AND THE CRUCIATE RETAINING FEMUR WAS REMOVED AND THE CORRECT POSTERIOR STABILIZED FEMUR WAS IMPLANTED".

  Patient problems: Injury

  MAUDE report 8864277 ↗
• InjuryJun 11, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "MAKO MPS OPENED A CR FEMUR AND IT WAS IMPLANTED ON A PS PREPPED FEMUR WITH A PS INSERT. I NOTICED WHEN I WAS LOOKING AT PAPERWORK THE NEXT DAY AND WENT STRAIGHT TO DOCTOR'S CLINIC TO NOTIFY HIM. REVISION WAS DONE TWO DAYS POST ORIGINAL SURGERY". UPDATE (B)(6) 2019 WG: AS REPORTED BY THE H.R. BUSINESS PARTNER: SPOKE TO MPS. MPS REPORTED HE PULLED THE IMPLANT BOX FROM THE CART AND HANDED IT TO THE SURGICAL STAFF WITHOUT OPENING IT.

  Patient problems: Injury

  MAUDE report 8687275 ↗
• InjuryMar 25, 2019Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "LOOSE LEFT TOTAL KNEE REPLACEMENT."

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8449151 ↗
• InjuryJul 27, 2018Unstable; Unstable

  IT WAS REPORTED THAT PATIENT'S LEFT KNEE WAS REVISED DUE TO INSTABILITY AND PAIN.

  Patient problems: Injury; Pain

  MAUDE report 7726549 ↗
• MalfunctionJul 27, 2017Fitting Problem; Device Operates Differently Than Expected; Scratched Material; Fitting Problem; Device Operates Differently Than Expected; Scratched Material

  IT WAS REPORTED THAT A PRESS FIT LEFT FEMUR HAD AN IMPROPER FIT. SURGEON RE-CUT AND STILL COULD NOT GET IT SEATED. SURGEON IMPLANTED A CEMENTED FEMUR INSTEAD. THERE WAS A 45 MINUTE SURGICAL DELAY BUT NO ADVERSE CONSEQUENCE TO PATIENT. REP STATED NO ADDITIONAL ANESTHESIA WAS ADMINISTERED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6747051 ↗