Triathlon 5517-F-602Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613327040999), received between Sep 18, 2017 and Aug 14, 2024 — classified as 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2024Malposition of Device; Malposition of Device

  PATIENT PRESENTED WITH PATELLA TRACKING ISSUES. DOCTOR REVISED THE FEMUR AND CHANGED TO A PS CONSTRUCT.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 19983142 ↗
• InjuryJun 13, 2022Malposition of Device; Naturally Worn; Malposition of Device; Naturally Worn

  REVISED A PRIMARY RIGHT KNEE TRIATHLON DUE TO MIS-BALANCING RESULTING IN MEDIAL POLY WEAR AND FEMUR RUBBING ON TIBIAL BASEPLATE. HE REVISED THE FEMUR, TIBIAL BASEPLATE AND POLY TO A COMPETITOR REVISION TOTAL KNEE.

  Patient problems: Insufficient Information

  MAUDE report 14682458 ↗
• InjuryFeb 18, 2021Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO LIGAMENT INSTABILITY. THE FEMORAL COMPONENT AND INSERT WERE REVISED. REP REPORTED HE CAN POSSIBLY PROVIDE PRIMARY AND REVISION USAGE, AND CONFIRMED THAT OTHERWISE NO FURTHER INFORMATION WOULD BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 11343686 ↗
• MalfunctionDec 22, 2020Mechanical Problem; Mechanical Problem

  EVENT: DOCTOR WAS IMPLANTING SIZE 6 RIGHT CR BEADED FEMUR WITH PA. NOTICED IMPLANT WAS NOT SEATING AS EXPECTED. OPENED SIZE 6 RIGHT CEMENTED FEMUR AND CEMENTED THE FEMUR ON. THERE WERE NO VISUAL IMPERFECTIONS TO THE REMOVED BEADED FEMUR. THE REMOVED FEMUR IS NOT AVAILABLE FOR RETURN SECONDARY TO HOSPITAL PROTOCOL. THERE WERE NO ADVERSE COMPLICATIONS TO THE PATIENT WITH THE CEMENTED FEMUR. NO ISSUES WITH OTHER IMPLANTS. THE SURGEON NOR THE PATIENT REQUEST RESULTS OF REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11056611 ↗
• InjuryNov 14, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO PAIN. A 5X9 CS INSERT AND SIZE 6 CR FEMUR WERE REVISED TO A SIZE 5 TS FEMUR WITH 12X100 STEM AND 5X11 PS INSERT. REP REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury; Pain

  MAUDE report 9323249 ↗
• 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 8688326 ↗
• InjuryOct 15, 2018Use of Device Problem; Use of Device Problem

  THIS PI IS FOR THE INCORRECT IMPLANTATION OF A PRIMARY DEVICE ON (B)(6) 2018. UPDATE PROVIDED FOR REVISION DETAILS: AFTER IMPLANTATION AND CLOSING THE PATIENT, IT WAS DISCOVERED THAT A CR FEMUR WAS IMPLANTED INSTEAD OF THE PS FEMUR THAT WAS PLANNED. AFTER DISCUSSING WITH SURGEON, PATIENT'S 5X9 PS INSERT WAS REVISED TO A 5X9 CS INSERT.

  Patient problems: Injury

  MAUDE report 7967390 ↗
• MalfunctionMar 27, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  FEMORAL PREPARATION OF BONE ON LATERAL CONDYLE DID NOT MATCH POSTERIOR CHAMFER CUT. CEMENTLESS FEMUR WAS REMOVED AND NEW FEMUR WAS CEMENTED ON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7373885 ↗
• InjurySep 18, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT SURGEON PERFORMED A REVISION OF PATIENT'S RIGHT KNEE DUE TO FEMORAL ROTATION.

  Patient problems: Injury

  MAUDE report 6873568 ↗