Triathlon 5536-B-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 07613327041507), received between Jul 10, 2017 and Jun 8, 2026 — classified as 19 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loss of Osseointegration” (6 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Mar 30, 2022Class IIOpen, Classified

   Stryker has discovered a potential product mix where the size of the Triathlon Tritanium Tibial Component inside the package does not match the package labeling.

   Z-1237-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryJun 8, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO A RUPTURED PATELLAR TENDON (NO TRAUMA WAS REPORTED). A CR/CS KNEE WAS CONVERTED TO A PS/ TS KNEE (PATELLAR COMPONENT WAS RETAINED). REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 25423499 ↗
• InjuryNov 19, 2024Unstable; Unstable

  PT. CALLED AND REPORTED THAT; THEY HAD A TOTAL KNEE REPLACEMENT TWO YEARS AGO ON THEIR RIGHT KNEE. THEY HAD A REVISION THIS YEAR FOR CHRONIC PAIN AND INSTABILITY. THE STRYKER IMPLANTS WERE REMOVED DURING THE REVISION AND REPLACED WITH A COMPETITOR PRODUCT. PT. WAS INFORMED THAT THEIR STRYKER IMPLANT HAD BEEN RECALLED.

  Patient problems: Joint Laxity; Pain

  MAUDE report 20721971 ↗
• InjuryAug 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED FOR SUSPECTED TIBIAL LOOSENING. HOWEVER, INTRA-OPERATIVELY, THE BASEPLATE WAS FOUND TO BE WELL FIXED. THE BASEPLATE WAS REVISED TO A UNIVERSAL BASEPLATE WITH STEM AND AUGMENTS. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 20009325 ↗
• InjuryNov 22, 2023Loss of Osseointegration; Loss of Osseointegration

  PATIENT WOULD LIKE TO KNOW IF KNEE IMPLANTS ARE SUBJECT TO A RECALL. PATIENT NOTED LOOSENING. (B)(6) 2023: UPDATE PER CONVERSATION WITH PATIENT: PATIENT REPORTED AN ASPIRATION.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 18189280 ↗
• InjuryApr 22, 2022Unstable; Unstable

  FOLLOW-UP OF TRIATHLON TRITANIUM OUTCOMES STUDY, PATIENT REPORTED DISSATISFACTION WITH THEIR KNEE REPLACEMENT. ADDITIONAL COMMENTS: "PAIN AFTER SITTING FOR LONG PERIOD AND NIGHT PAIN. DISAPPOINTED WITH PAIN AND FEELS LOOSE."

  Patient problems: Joint Laxity; Pain

  MAUDE report 14187049 ↗
• InjuryMar 1, 2022Osseointegration Problem; Osseointegration Problem

  PATIENT HAD A BILATERAL TKA IN JUNE 9, 2020. PATIENT DEVELOPS PAIN AND REQUIRES (RIGHT KNEE) REVISION ON (B)(6) 2021. THE TIBIAL COMPONENT WAS LOOSE.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 13640490 ↗
• InjuryApr 27, 2021Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO PAIN. A SIZE 5 TRITANIUM TIBIAL COMPONENT, SIZE 5CR FEMORAL COMPONENT, AND INSERT WERE REVISED TO A SIZE 5 UNIVERSAL BASEPLATE, SIZE 5PS FEMORAL COMPONENT, AND INSERT. SURGEON'S OPINION WAS THAT THE TIBIAL COMPONENT WAS IMPLANTED WITH TOO MUCH VARUS. THERE ARE NO ALLEGATIONS AGAINST THE INSERT. FEMORAL COMPONENT WAS REVISED TO INCREASE KNEE ROTATION, BUT OTHERWISE THERE ARE NO ALLEGATIONS AGAINST THE FEMORAL COMPONENT.

  Patient problems: Pain

  MAUDE report 11730570 ↗
• InjuryMar 18, 2021Loss of Osseointegration; Unintended Movement; Loss of Osseointegration; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO LOOSENING AND SUBSIDENCE OF THE TIBIAL BASEPLATE. A SIZE 5 TRITANIUM TIBIAL BASEPLATE AND UNKNOWN LINER WERE REVISED TO A UNIVERSAL BASEPLATE WITH STEM AND NEW LINER. THERE ARE NO ALLEGATIONS AGAINST THE REVISED LINER.

  Patient problems: Insufficient Information

  MAUDE report 11512893 ↗
• InjuryDec 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION USAGE SHEET THAT THE PATIENT'S LEFT KNEE WAS REVISED. A SIZE 5 TRIATHLON TIBIAL COMPONENT AND 5 X 13 CS INSERT WERE REVISED TO A SIZE 4 TRIATHLON TIBIAL COMPONENT AND 4 X 14 CS INSERT. SPOKE TO REP, PATIENT WAS REVISED ONE DAY AFTER THE PRIMARY. SURGEON NOTICED SOME MEDICAL OVERHANG ON THE TIBIAL COMPONENT WHICH HAD SHIFTED. SURGEON TOOK OUT LINER AND TIBIAL COMPONENT AND DOWNSIZED BOTH. WHEN DOWNSIZING THE POLY, SURGEON DECIDED TO INCREASE THE THICKNESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11044945 ↗
• InjuryDec 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PATIENT FRACTURED HER [LEFT] PROXIMAL TIBIA. SURGEON REVISED THE BASEPLATE AND ADDED A CONE. THE FEMUR AND PATELLA ARE NOT INVOLVED. X-RAY SHOWING FRACTURE, ORIGINAL SURGERY SHEET, AND REVISION SURGERY SHEET WERE PROVIDED. REP, CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED LINER AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY HOSPITAL OR SURGEON.

  Patient problems: Bone Fracture(s)

  MAUDE report 10982150 ↗
• InjuryOct 19, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED. A SIZE 5 TIBIAL COMPONENT, 5X11 CS INSERT, AND SIZE 5 CR FEMORAL COMPONENT WERE REVISED TO A SIZE 4 PS FEMORAL COMPONENT, 4X16 PS INSERT, SIZE 4 UNIVERSAL BASEPLATE, AND 12X50 STEM. REPORTING REP WAS NOT PRESENT FOR THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 10697503 ↗
• InjuryOct 16, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO FEMORAL AND TIBIAL LOOSENING. THE LINER, PS FEMORAL COMPONENT, AND TIBIAL BASEPLATE WERE REVISED TO COMPETITOR DEVICES. THERE ARE NO ALLEGATIONS AGAINST THE LINER. THERE IS NO INFORMATION AVAILABLE ABOUT THE PRIMARY SURGERY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 10688757 ↗
• InjuryApr 14, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  REP FAXED IN A PER FORM WITH A BLANK EVENT DESCRIPTION. SPOKE TO REP. REP WAS NOTIFIED THAT THE PATIENT'S ANTERIOR TIBIA COLLAPSED. THE PATIENT HAS NOT YET BEEN REVISED. REVISION DATE IS UNKNOWN AS CASES ARE BEING EVALUATED BEFORE THEY CAN BE PERFORMED. PATIENT ALLEGES THAT THEY EXPERIENCED NO FALLS OR OTHER TRAUMA.

  Patient problems: Injury; Limb Fracture; Pain

  MAUDE report 9957173 ↗
• InjuryMar 25, 2020Migration or Expulsion of Device; Inadequacy of Device Shape and/or Size; Loss of Osseointegration; Malposition of Device; Migration or Expulsion of Device; Inadequacy of Device Shape and/or Size; Loss of Osseointegration; Malposition of Device

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO SUBSIDENCE OF THE TIBIAL BASEPLATE DUE TO THE BASEPLATE BEING TOO SMALL FOR THE PATIENT'S ANATOMY. THERE ARE NO ALLEGATIONS AGAINST THE BASEPLATE'S MANUFACTURED DIMENSIONS. A CR KNEE CONSTRUCT WAS REVISED TO A PS CEMENTED FEMUR, UNIVERSAL BASEPLATE WITH STEM, A NEW INSERT, AND CONE. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED FEMUR OR INSERT. REP CAN PROVIDE SOME PHOTOS AND REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Inadequate Osseointegration; Injury

  MAUDE report 9881074 ↗
• InjuryJun 6, 2019Loss of Osseointegration; Loss of Osseointegration

  THIS PI IS FOR REVISION OF PRIMARY IN (B)(6) 2014. IN REPORTING A REVISION OF THE PATIENT'S LEFT KNEE IN (B)(6) 2019, REP PROVIDED AN OPERATIVE REPORT FOR A REVISION IN (B)(6) 2014. THE OPERATIVE REPORT STATES "PREOPERATIVE DIAGNOSES: PAINFUL RIGHT TOTAL KNEE ARTHROPLASTY. PROBABLE LOOSENING OF TIBIAL COMPONENT, PAIN IN THE RIGHT KNEE, MOSTLY IN THE PROXIMAL RIGHT LOWER LEG. X-RAYS HAD SHOWN DEVELOPMENT OF AN OSTEOLYTIC AREA UNDER THE MEDIAL TIBIAL PLATEAU WITH A SCLEROTIC HALO ABOUT THE TIBIAL KNEE. THE OVERALL APPEARANCE WAS CONSISTENT WITH LOOSENING. THE TIBIAL COMPONENT WAS NOT GROSSLY LOOSE, BUT FOLLOWING RETRIEVAL AND INSPECTION OF THE UNDERSURFACE OF THE BASE PLATE, THERE DID NOT APPEAR TO BE ANY BONE INGROWTH. THERE WAS CONSIDERABLE FIBROSIS INGROWTH, HOWEVER. MY SUSPICION IS THAT THE PATIENT HAD OSTEONECROSIS OF THE MEDIAL TIBIAL PLATEAU, PROBABLY FOLLOWING A STRESS OR INSUFFICIENCY FRACTURE IN THE METAPHYSEAL BONE.

  Patient problems: Fibrosis; Inadequate Osseointegration; Injury; Pain

  MAUDE report 8675470 ↗
• InjuryDec 28, 2018Migration; Migration

  IT WAS REPORTED THAT PATIENT'S LEFT KNEE WAS REVISED DUE TO MEDIAL TIBIAL COMPRESSION. NO POSSIBLE CAUSES OR CONTRIBUTORS FOR COMPRESSION WERE REPORTED TO THE REP. A TRITANIUM BASEPLATE AND CS INSERT WERE REVISED TO A SIZE 5 UNIVERSAL BASEPLATE WITH 12X100 STEM AND A 5X11 CS INSERT.

  Patient problems: Injury

  MAUDE report 8204502 ↗
• InjuryDec 11, 2018Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT PATIENT'S RIGHT KNEE WAS REVISED DUE TO A BROKEN TIBIAL BASEPLATE. NO TRAUMA OR OTHER POSSIBLE CAUSES/ CONTRIBUTORS TO IMPLANT BREAKAGE WERE REPORTED. WHEN THE BASEPLATE WAS REMOVED, THE KEEL AND ONE OF THE CRUCIFORM PEGS REMAINED IN THE BONE AND HAD TO BE REMOVED SEPARATELY. PATIENT WAS REVISED TO A UNIVERSAL BASEPLATE WITH A 100MM CEMENTED STEM.

  Patient problems: Injury

  MAUDE report 8152535 ↗
• MalfunctionSep 5, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  PRIMARY PROCEDURE, LEFT KNEE. PATIENT WAS TRAILED FOR A SIZE 5 BASEPLATE, WHICH COVERED THE TIBIAL CUT. AFTER USING THE GUIDE TO PUNCH THE 4 PRESS-FIT PEG HOLES, THE IMPLANT WAS PLACED AND DID NOT COVER THE TIBIAL CUT THOUGH THE PEGS FIT INTO THE HOLES SET BY THE GUIDE. SURGEON DECIDED THAT AS THE IMPLANT WAS STABLE WITH NO MOVEMENT, THERE WOULD BE NO PATIENT HARM BY LEAVING THE IMPLANT IN. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAYS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7848252 ↗
• MalfunctionDec 11, 2017Device Contamination with Chemical or Other Material; Packaging Problem; Device Contamination with Chemical or Other Material; Packaging Problem

  SURGEON WAS PERFORMING A TOTAL KNEE ARTHROPLASTY. AFTER A #5 TRIATHLON TRITANIUM TIBIAL COMPONENT WAS OPENED ON THE STERILE FIELD HE NOTICED A GREEN SUBSTANCE ON THE BOTTOM OF THE TIBIA. HE REFUSED TO IMPLANT IT AND A REPLACEMENT WAS OPENED AND IMPLANTED WITHOUT INCIDENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7105651 ↗
• InjuryOct 23, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SALES REP REPORTED PATIENT HAD KNEE REVISION. UPDATE PER MEDICAL REVIEW: THE PATIENTS' REVISION WAS DUE TO A PERIPROSTHETIC FRACTURE.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 6969917 ↗
• InjuryJul 10, 2017Loss of Osseointegration; Malposition of Device; Loss of Osseointegration; Malposition of Device

  COMPANY REPRESENTATIVE REPORTED PATIENT HAD LEFT KNEE REVISION DUE TO RELATIVE LOOSENING OF TIBIAL COMPONENT WITH VARUS ALIGNMENT AND LATERAL COMPONENT LIFTOFF.

  Patient problems: Ambulation or Postural Difficulties; Inadequate Osseointegration; Injury

  MAUDE report 6698772 ↗