Triathlon 5517-F-702Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327041019), received between Oct 9, 2018 and Feb 17, 2026 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Unstable” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 17, 2026Loss of Osseointegration

  THE FOLLOWING INFORMATION WAS PROVIDED: SURGEON DID REVISION OF RIGHT STRYKER PRESSFIT CR FEMUR AND BASEPLATE AFTER 1 YEAR OUT OF SURGERY - SURGEON DID NOT PERFORM THE PRIMARY SURGERY JUST THE REVISION AND WANTS TO SEND BACK FEMORAL COMPONENT. HE BELIEVES NOT ENOUGH BONE GROWTH WAS ON THE FEMUR. AS REPORTED BY HOSPITAL MANAGEMENT: I INCLUDED THE TIBIA SO YOU CAN SEE THERE IS BONE GROWTH. THE FEMUR HAS SOME TOO. THE PATIENT IS A YEAR OR SO OUT. THE SURGEON FELT IT DID NOT HAVE ENOUGH BONE GROWTH ON THE FEMUR.

  Patient problems: Ambulation or Postural Difficulties; Inadequate Osseointegration

  MAUDE report 24363026 ↗
• InjuryFeb 7, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THIS PI IS FOR THE SOFT TISSUE REALIGNMENT PROCEDURE. IN REPORTING A REVISION OF THE PATIENT'S RIGHT KNEE ON (B)(6) 2022, REP REPORTED THAT IN (B)(6) OF 2021 THE PATIENT FELL AND DISLOCATED THEIR RESURFACED PATELLA. A SOFT TISSUE REALIGNMENT WAS PERFORMED. REP CONFIRMED THAT NO STRYKER REP WAS PRESENT FOR THE PROCEDURE AS THE SURGEON DID NOT GO INTO THE PATIENT'S JOINT SPACE OR REVISE ANY IMPLANTS. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Fall

  MAUDE report 13471335 ↗
• InjuryJan 4, 2022Unstable; Malposition of Device; Unstable; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO MALPOSITION AND INSTABILITY. INTRA-OPERATIVELY THE FOLLOWING WAS NOTED: SLIGHT MALPOSITION OF FEMORAL COMPONENT, WORN INSERT WITH BROKEN LOCKING WIRE, AND BROKEN TIBIAL BASEPLATE. THE BASEPLATE WAS BROKEN MEDIALLY 1/3 OF THE WAY THROUGH THE ANTERIOR MEDIAL SPIKE. THE PATIENT WAS REVISED TO A TS KNEE WITH A UNIVERSAL BASEPLATE AND STEMS.

  Patient problems: Joint Laxity

  MAUDE report 13150845 ↗
• MalfunctionMar 2, 2020Fitting Problem; Fitting Problem

  FEMUR CUT WITH MAKO, TRIAL SEEMED TO FIT WELL, PLACED PA BEADED FEMUR SIZE 7 RIGHT IMPLANT ON AND DID NOT SEEM TO FIT PROPERLY. OFF ON ANTERIOR CHAMFER AND ANTERIOR CUT APPROX 2-3MM. HAD TO OPEN ANOTHER IMPLANT AND. CEMENT FEMUR. HAD TO CEMENT FEMUR MEANT CASE TOOK APPROX 15MIN LONGER. CASE TYPE: TKA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9775744 ↗
• InjuryDec 30, 2019Migration; Migration

  KNEE REVISION POLY WEAR. COMMENT IN ADVERSE CONSEQUENCES DETAILS: PATIENT NEEDED KNEE REVISION DUE TO INSTABILITY. *UPDATE: BASED ON MEDICAL REVIEW, X-RAYS DATED (B)(6) 2019 ARE AN AP, FOUR LATERALS, AND ONE PATELLAR VIEW OF THE RIGHT KNEE, WHICH IS ESSENTIALLY UNCHANGED FROM THE PREVIOUS STUDY, BUT THE POSTERIOR SUBLUXATION OF THE FEMORAL COMPONENT IS NOTED ON THE LATERAL X-RAYS.

  Patient problems: Injury; Joint Disorder

  MAUDE report 9530775 ↗
• InjuryJul 3, 2019Inadequacy of Device Shape and/or Size; Unstable; Osseointegration Problem; Inadequacy of Device Shape and/or Size; Unstable; Osseointegration Problem

  "MY KNEE SPACER IS SLIGHTLY LOOSE AND MY PHYSICIAN, A MAN I LIKE AND TRUST AS A QUALITY SURGEON, TOLD ME THAT THE SPACERS COME IN TWO MILLIMETER INCREMENTS AND HE GAVE ME A SIZE CLOSE AS POSSIBLE GIVEN MY ANATOMY BUT TO REPEAT, MINE IS SLIGHTLY LOOSE AND SLIPS LATERALLY, CREATING A LACK OF ABILITY TO EVEN STAND NORMALLY ON MY LEG, WHICH CAUSES ME TO FAVOR THE LEG UNNATURALLY, GIVING ME CHRONIC LOW BACK AND HIP DISCOMFORT, WHICH IS NOT HORRIBLE, BUT IT IS NAGGING." UPDATE 10-MAY-2018: AS PER OPT REPORT, RIGHT KNEE REPLACEMENT WAS DONE ON (B)(6) 2018. PATIENT HAD A MANIPULATION DONE ON (B)(6) 2018. UPDATE 11 JUNE 2018 (B)(6): AS PER MEDICAL REVIEW, PATIENT HAD A MANIPULATION DONE ON (B)(6) 2018 BECAUSE OF LIMITED KNEE FLEXION TO 90° WITH FULL EXTENSION. [...] SURGICAL ERROR IN CHOICE OF FEMORAL COMPONENT SIZE BETWEEN INTENDED AND BIGGER COMPONENT ACTUALLY IMPLANTED HAS CONTRIBUTED TO A STIFFNESS PROBLEM IN THE KNEE IN AN ARTHROPLASTY THAT IN GENERAL IS ALREADY AT RISK FOR SCAR TISSUE FORMATION WITH RESULTING ARTHROFIBROSIS. MANIPULATION OF THE KNEE UNDER ANAESTHESIA IMPROVED KNEE FUNCTIONALITY TO NORMAL ALTHOUGH THERE IS NO RECENT INFORMATION AVAILABLE ABOUT RETENTION OF ADEQUATE KNE

  Patient problems: Discomfort; Inadequate Osseointegration; Injury; Loss of Range of Motion; Pain

  MAUDE report 8758394 ↗
• InjuryOct 9, 2018Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  SURGEON REPORTED THAT PATIENT DEVELOPED RECURRENT EFFUSIONS FOLLOWING TOTAL KNEE REPLACEMENT WITH STRYKER TRIATHLON CEMENTLESS COMPONENTS. DUE TO MULTIPLE PATIENT ALLERGIES, PATIENT WAS THEN TESTED FOR METAL ALLERGIES, WHICH CAME BACK POSITIVE FOR ALLERGY TO NICKEL. REVISION WAS SCHEDULED AND PERFORMED ON (B)(6) 2018, REMOVING FEMUR, POLY INSERT, AND TIBIAL COMPONENT. TRITANIUM PATELLA WAS RETAINED. REVISION WITH NICKEL FREE IMPLANTS FROM [COMPETITOR] WAS PERFORMED.

  Patient problems: Injury; Reaction

  MAUDE report 7948873 ↗