Triathlon 5521-B-400Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 07613327026061), received between Aug 24, 2017 and Sep 10, 2024 — classified as 26 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loss of Osseointegration” (10 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. May 19, 2026Class IIOpen, Classified

   Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon Universal Baseplate Size 4 (lot TYX7OB), is contained in packaging labeled as Triathlon Universal Baseplate Size 3, (lot UZD9IB).

   Z-2462-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2024Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY ON OR ABOUT (B)(6) 2016, THE PATIENT UNDERWENT A RIGHT TKA WITH STRYKER COMPONENTS. ALLEGEDLY ON OR ABOUT (B)(6) 2022, THE PATIENT LEARNED THAT THE FEMORAL STEM HAD FRACTURED AND SEPARATED FROM THE FEMORAL CONDYLAR COMPONENT OF THE FEMORAL PART OF THE PROSTHESIS. THE PATIENT WAS REVISED ON (B)(6) 2023. UPDATE PER MEDICAL RECORDS RECEIVED: THE BASEPLATE WAS REVISED DUE TO TIBIAL LOOSENING.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 20181557 ↗
• InjuryJun 30, 2024Loss of Osseointegration; Loss of Osseointegration

  PATIENT HAD A RIGHT KNEE REVISION DUE TO FEMUR AND TIBIAL COMPONENTS LOOSENING. NO OTHER DETAILS ARE AVAILABLE BY THE FACILITY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19640955 ↗
• InjuryJun 13, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  LEFT KNEE COMPLAINTS OF RADIATING PAIN, LOCKING AND POPPING SENSATIONS WITH INSTABILITY. REVISED (B)(6) 2018 WITH TIBIAL PERIPROSTHETIC FRACTURE NOTED. TIBIAL BASEPLATE AND INSERT WERE REVISED.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 19528871 ↗
• InjuryJan 14, 2024Loss of Osseointegration; Loss of Osseointegration

  DOCTOR REVISED A RIGHT TRIATHLON TS TO A NEW TS DUE TO PATIENT COMPLAINING OF PAIN. BOTH FEMUR AND TIBIA WERE LOOSE.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 18509821 ↗
• InjuryAug 30, 2023Unintended Movement; Migration; Unintended Movement; Migration

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO LATERAL SUBSIDENCE OF THE TIBIA AFTER THE PATIENT HAD AN 'ACCIDENT' (NATURE OF THE ACCIDENT NOT REPORTED TO THE REP). THE BASEPLATE AND PS INSERT WERE REVISED TO A BASEPLATE WITH STEM, AUGMENTS AND CONE WITH A TS INSERT (REP CONFIRMED THE SURGEON WANTED ADDITIONAL STABILITY FOR THE PATIENT'S CONSTRUCT, THERE WERE NO ALLEGATIONS AGAINST THE REVISED INSERT). REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 17648838 ↗
• InjuryMay 15, 2023Loss of Osseointegration; Loss of Osseointegration

  AS REPORTED: "PATIENTS RIGHT KNEE WAS REVISED DUE TO LOOSENING." SPOKE TO REP. BOTH THE BASEPLATE AND FEMORAL COMPONENT WERE LOOSE. THE PATIENT'S ENTIRE KNEE CONSTRUCT WAS REVISED.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 16928891 ↗
• InjuryOct 11, 2022Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO TIBIAL SUBSIDENCE. THE PATIENT'S ENTIRE KNEE CONSTRUCT WAS REVISED. REP CONFIRMED THERE WERE NO ALLEGATIONS AGAINST THE IMPLANTS. REP ALSO PROVIDED THE USAGE SHEET FOR THE REVISION AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 15580150 ↗
• InjurySep 2, 2021Crack; Loss of Osseointegration; Crack; Loss of Osseointegration

  IT WAS REPORTED BY PATIENT'S WIFE, PATIENT HAD A RIGHT TKA ON 2010 (APPROX). WITHIN A YEAR OF THE SURGERY PATIENT STARTED TO EXPERIENCE PAIN AND SWELLING. THE PATIENT FOLLOWED UP WITH HIS SURGEON AND WAS TOLD HE HAD AN INFECTION AND WAS REVISED ON 2012 (APPROX). THE PATIENT WAS IMPLANTED WITH AN ANTIBIOTIC SPACER AND APPROX 3-5 MONTHS LATER THE PATIENT WAS IMPLANTED. EARLY THIS YEAR THE PATIENT STARTED TO EXPERIENCE PAIN. ON (B)(6), 2021 THE PATIENT FOLLOWED UP WITH HIS SURGEON WHERE AN X-RAY WAS TAKEN AND WAS TOLD THAT HIS IMPLANT WAS CRACKED. THE SURGEON RECOMMENDED REVISION. PATIENT WOULD LIKE SOME ASSISTANCE WITH MEDICAL BILLS AND REVISION SURGERY. PATIENT IS SEEKING COMPENSATION. THIS PI IS FOR PAIN AFTER REVISION. UPDATE: "NEW SURGERY THAT HAPPENED (B)(6), TO REPLACE THE CRACKED PROSTHETIC." UPDATE 03/FEB/2022: REVIEW OF MEDICAL FILES INDICATED LOOSENING OF BOTH TIBIAL AND FEMORAL COMPONENTS. UPDATE 17/FEB/2022: TIBIAL PLATEAU FRACTURE AND ARTHROFIBROSIS WERE IDENTIFIED INTRA-OPERATIVELY DURING THE REVISION PROCEDURE. UPDATE 11-APRIL-2022: FEMORAL COMPONENTS WERE INDICATED TO BE "WELL-POSITIONED, WELL-FIXED" IN REVISION OP REPORT, AND THEY WERE NOT EXPLANTED.

  Patient problems: Ambulation or Postural Difficulties; Bone Fracture(s); Fibrosis; Inflammation; Pain

  MAUDE report 12413549 ↗
• InjuryJul 6, 2021Unstable; Loss of Osseointegration; Unstable; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED. AS REPORTED BY REP: "SHE PRESENTED IN 2021 WITH GROSS INSTABILITY AND A COLLAPSED MEDIAL TIBIA. AT TIME OF SURGERY IT WAS NOTED THAT THE CEMENT INTERFACE WAS LOOSE. CULTURES AND GRAM STAINS WERE NEGATIVE RULING OUT INFECTION. WE REMOVED ALL BUT PATELLA, REVISED TO TRIATHLON TOTAL STABILIZER SUCCESSFULLY." PRIMARY AND REVISION USAGE WERE PROVIDED. SPOKE TO THE REP, WHO CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12123192 ↗
• InjuryJul 1, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS IS WHAT WAS PROVIDED IN AN EMAIL: PATIENT STATES THEY HAD A KNEE REPLACEMENT THIS PAST JUNE AND DEVELOPED AN ALLERGY TO THE KNEE AND IT'S COMPONENTS. PATIENT HAD TO HAVE LEG AMPUTATED BECAUSE OF THIS. UPDATE: MEDICAL RECORDS RECEIVED CITE A METAL ALLERGY.

  Patient problems: Inflammation; Injury; Reaction

  MAUDE report 10216752 ↗
• InjuryJun 16, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO LOOSENING. REVISING SURGEON REPORTED THAT CAUSE OR CONTRIBUTOR TO LOOSENING WAS DUE TO THE PRIOR SURGEON NOT USING ENOUGH CEMENT. THE PATIENT'S ENTIRE KNEE CONSTRUCT WAS REVISED. REP PROVIDED EXPLANT PICTURES AND REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Injury

  MAUDE report 10157040 ↗
• InjuryApr 6, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO PAIN. AS REPORTED BY REP: "REVISED FOR PAIN AND LOOSENING. NO ALLEGATIONS AGAINST THE IMPLANTS. PATIENT HAS AVASCULAR NECROSIS WHICH CAUSED THE FAILURE." REP PROVIDED PRIMARY AND REVISION USAGE SHEETS AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED.

  Patient problems: Injury; Pain

  MAUDE report 9929456 ↗
• InjuryNov 19, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  DR. REVISED A LEFT TOTAL KNEE TRIATHLON ORIGINALLY DONE ON (B)(6) 2018. PATIENT WAS EXPERIENCING PAIN. HE ASSESSED THE IMPLANTS TO BE STABLE, HOWEVER DECIDED TO EXTRACT THE TIBIAL BASEPLATE AND AFTER WHICH HE OBSERVED THERE WAS POSTERIOR TIBIAL FRACTURE. HE REVISED TO A CONE IMPLANT WITH A NEW UNIVERSAL BASEPLATE, AUGMENTS, STEM AND INSERT.

  Patient problems: Bone Fracture(s); Injury; Pain

  MAUDE report 9340575 ↗
• InjurySep 24, 2019Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO PROGRESSIVE RADIOLUCENCY AROUND THE TIBIAL AND FEMORAL STEMS. A KNEE CONSTRUCT WITH TIBIAL BASEPLATE AND STEM, FEMORAL COMPONENT AND STEM, AND A CS INSERT WERE REVISED TO A TS CONSTRUCT. REP PROVIDED A WEBOPS REPORT, AN EXCERPT FROM AN OPERATIVE REPORT, EXPLANT PICTURES AND X-RAYS FROM (B)(6) 2019 AND REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 9109429 ↗
• InjurySep 10, 2019Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO PAIN AND LOSS OF FUNCTION. INTRA-OPERATIVELY, THE FOLLOWING WAS NOTED: THE SIZE 5 CEMENTED FEMORAL COMPONENT WAS LOOSE; THERE WAS A FRACTURE AT THE JUNCTION OF THE FEMORAL STEM AND 12X100 STEM; THE CEMENTED TIBIAL COMPONENT WAS LOOSE; THE JUNCTION OF THE STEM EXTENDER AND 12X50 STEM ON THE TIBIAL SIDE WAS LOOSE. THE PATIENT'S ENTIRE TS KNEE CONSTRUCT (INCLUDING FIVE AUGMENTS) WAS REVISED TO A TRIATHLON TS KNEE CONSTRUCT WITH A CONE. REP PROVIDED ONE PAGE OF THE PRIMARY OPERATIVE REPORT, AND REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration; Injury; Pain

  MAUDE report 8982229 ↗
• InjurySep 4, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO PAINFUL LEFT TOTAL KNEE WITH OSTEOLYSIS OF THE TIBIAL COMPONENT, POLYETHYLENE WEAR.

  Patient problems: Injury; Osteolysis; Pain

  MAUDE report 8960144 ↗
• InjuryAug 14, 2019Osseointegration Problem; Osseointegration Problem

  REVISION LEFT TOTAL KNEE REPLACEMENT. REMOVED TRIATHLON UNIVERSAL BASEPLATE & FLUTED STEM & PS INSERT FOR LOOSENING. REVISED WITH TRIATHLON UNIVERSAL BASEPLATE, CEMENTED TIBIAL STEM & TS INSERT. PREVIOUS REVISION SURGERY CONDUCTED AT (B)(6) IN (B)(6) 2014.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8892297 ↗
• InjuryJun 11, 2019Unstable; Unstable

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO " FAILED LEFT TOTAL KNEE REPLACEMENT, INSTABILITY AND SUSPECTED LOOSE OR MALPOSITIONED PATELLAR COMPONENT"

  Patient problems: Injury

  MAUDE report 8686918 ↗
• InjuryApr 11, 2019Unstable; Unstable

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "RIGHT TOTAL KNEE ARTHROPLASTY FAILURE WITH POLYETHYLENE WEAR, OSTEOLYSIS, AND ANTERIOR TO POSTERIOR INSTABILITY".

  Patient problems: Injury; Osteolysis

  MAUDE report 8505341 ↗
• InjuryApr 11, 2019Unstable; Unstable

  IT WAS REPORTED THE PATIENT WAS REVISED DUE TO "FAILED RIGHT TOTAL KNEE ARTHORPLASTY (CHRONIC PROGRESSIVE INSTABILITY)".

  Patient problems: Injury

  MAUDE report 8504344 ↗
• InjuryMar 14, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "REVISION LEFT TOTAL KNEE ARTHROPLASTY, ONE COMPONENT ONLY. FINDINGS: MULTIDIRECTIONAL INSTABILITY, ANTERIORLY MEDIALLY AND LATERALLY; POSTERIORLY STABILIZED."

  Patient problems: Ambulation or Postural Difficulties; Injury

  MAUDE report 8420254 ↗
• InjuryJan 15, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE SUBMISSION OF A PRIMARY AND REVISION IMPLANT SHEET THAT PATIENT'S RIGHT KNEE WAS REVISED. A TRIATHLON CS CONSTRUCT (BASEPLATE, FEMORAL COMPONENT, INSERT) WAS REVISED TO A 9 DEVICE TS CONSTRUCT INCLUDING STEMS, AUGMENTS, ADAPTER, AND A PATELLA.

  Patient problems: Injury

  MAUDE report 8250711 ↗
• InjuryDec 18, 2018Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THROUGH THE SUBMISSION OF A PRIMARY AND A REVISION IMPLANT SHEET, THAT THE PATIENT'S RIGHT KNEE WAS REVISED. COMPARING THE SHEETS, A 4X11 CS INSERT AND SIZE 4 UNIVERSAL TIBIAL BASEPLATE WERE REVISED TO A 4X19 CS INSERT, ANOTHER SIZE 4 UNIVERSAL TIBIAL BASEPLATE WITH A 12X100 CEMENTED STEM AND 4X5 TIBIAL AUGMENT. IT WAS LATER REPORTED THAT THE PATIENT'S GRANDSON JUMPED ON PATIENT'S KNEE WHICH CAUSED LOOSENING OF THE TIBIAL COMPONENT. THE TIBIAL COMPONENT AND LINER WERE REVISED AS ORIGINALLY REPORTED.

  Patient problems: Injury

  MAUDE report 8174007 ↗
• InjuryNov 12, 2018Loss of Osseointegration; Loss of Osseointegration

  PATIENT REPORTED HE IS EXPERIENCING LOOSENING AND PAIN AFTER HIS RIGHT KNEE SURGERY.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 8060120 ↗
• MalfunctionJan 30, 2018Packaging Problem; Packaging Problem

  PRIMARY PROCEDURE, LEFT TKR. REP REPORTED THAT A BOX MARKED FOR A SIZE 4 TIBIAL BASEPLATE WAS OPENED AND THE DEVICE INSIDE IMPLANTED. UPON TRIALING FOR THE INSERT, SIZE 4 TRIAL WOULD NOT FIT. UPON EXAMINATION IT WAS DISCOVERED THE IMPLANT WAS A SIZE 3. THE SURGEON HAD CONSIDERED BOTH SIZE 3 AND 4 IMPLANTS PRIOR TO IMPLANTATION, AND REPORTED THAT THE SIZE 3 IMPLANT WOULD REMAIN IN THE PATIENT. REP CONFIRMS HE WAS IN THE O.R. AT THE TIME OF OPENING AND IMPLANTATION. REP HAS PICTURES OF THE IMPLANT AND THE PACKAGING, AND WILL BE RETURNING THE PACKAGING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7229452 ↗