Triathlon 5521-B-300Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 07613327026313), received between Mar 29, 2017 and Aug 18, 2026 — classified as 17 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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-2461-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryAug 18, 2026Unintended Movement

  It was reported the patient's Left knee was revised due to collapse of the medial tibia. A PS knee was converted to a TS Revision knee with cemented Universal baseplate. Rep confirmed there were no allegations against the revised insert, and that no further information will be released by the hospital or surgeon.

  Patient problems: Insufficient Information

  MAUDE report 50308317 ↗
• InjurySep 19, 2025Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  NO NEW INFORMATION.

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

  MAUDE report 23097683 ↗
• InjuryApr 21, 2025Failure to Osseointegrate; Malposition of Device; Failure to Osseointegrate; Malposition of Device

  AS REPORTED: "REV LTKA- FOR LOOSE TIBIA AND MAL ALIGNMENT." A PS KNEE WAS CONVERTED TO A TS KNEE WITH STEMS AND AUGMENTS. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties; Inadequate Osseointegration

  MAUDE report 21875879 ↗
• InjuryMay 31, 2024Malposition of Device; Migration; Malposition of Device; Migration

  IT WAS REPORTED BY SALE REP THAT THERE IS REVISION SURGERY PERFORMED DUE TO TIBIA INTERNAL ROTATION, NEW TIBIA AND STEM WERE REPLACED. THE PRIMARY SURGERY PERFORMED OUTSIDE THAILAND BACK IN 2020 SO PRODUCT INFORMATION FOR PRIMARY SURGERY COULD NOT BE IDENTIFIED.

  Patient problems: Insufficient Information; Pain

  MAUDE report 19433182 ↗
• InjuryNov 17, 2023Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO LOOSENING OF THE TIBIAL COMPONENT. A TS KNEE CONSTRUCT WAS REVISED TO ANOTHER TS CONSTRUCT WITH ADDITIONAL AUGMENTS. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18158198 ↗
• InjuryMar 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TOTAL RIGHT KNEE TIBIAL REVISION DUE TO CLOSED FRACTURE OF LATERAL TIBIAL. CONVERTED PRIMARY TIBIAL TRAY TO A STEMMED TIBIAL TRAY.

  Patient problems: Bone Fracture(s)

  MAUDE report 16626226 ↗
• InjuryAug 17, 2021Fracture; Loss of Osseointegration; Fracture; Loss of Osseointegration

  AS REPORTED: "PATIENT IS A 57-YEAR-OLD FEMALE WHO PREVIOUSLY UNDERWENT RIGHT TOTAL KNEE REPLACEMENT - OUTSIDE CORS SCOPE (ROI IN 2016). SHE UNDERWENT REVISION FOR TIBIAL COMPONENT LOOSENING (B)(6) 2017, ALL COMPONENTS REVISED. PATIENT REQUIRED A SECOND REVISION DUE TO ASEPTIC LOOSENING OF FEMORAL COMPONENT PERFORMED IN (B)(6) 2020. ALL COMPONENTS WHERE EXCHANGED." AN OP REPORT WAS PROVIDED WHICH CITED ASEPTIC LOOSENING OF THE TIBIA, AND "AROUND THE FEMUR, THERE WAS ALSO EXTENSIVE AMOUNT OF BONE LOSS AND THE FEMUR APPEARED TO BE ALSO LOOSE. WE THEREFORE DECIDED TO REMOVE BOTH COMPONENTS..."

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

  MAUDE report 12334634 ↗
• InjuryJul 21, 2021Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO ASEPTIC LOOSENING OF THE FEMORAL AND TIBIAL IMPLANTS. THE PATIENT'S KNEE WAS REVISED TO A GMRS KNEE. REVISING SURGEON REPORTED THE INDEX SURGEON DID NOT USE ENOUGH CEMENT ON THE ORIGINAL IMPLANTS. REP CONFIRMED THAT THERE ARE NO ALLEGATIONS AGAINST THE REVISED LINER. REP ALSO PROVIDED EXPLANT PICTURES AND REVISION USAGE, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12201255 ↗
• InjuryMay 27, 2021Loss of Osseointegration; Loss of Osseointegration

  RIGHT TS TIBIAL BASEPLATE HAD ASEPTIC LOOSENING, POSSIBLY DUE TO A FRACTURE IN THE TIBIAL PLATEAU DURING THE PREVIOUS IMPLANTING OF THE BASEPLATE. THE SURGEON REMOVED THE TS BASEPLATE AND REPLACED IT WITH A TIBIAL SYMMETRIC CONE, AUGMENTS, STEM AND NEW UNIVERSAL BASEPLATE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11892221 ↗
• InjuryFeb 11, 2021Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO LOOSENING OF THE TIBIAL BASEPLATE. THE BASEPLATE AND INSERT WERE REVISED. REP CONFIRMED THAT THERE ARE NO ALLEGATIONS AGAINST THE REVISED INSERT, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11318851 ↗
• InjuryJul 20, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS PI IS FOR REVISION 1. PATIENT HAD A RIGHT TKA DONE ON (B)(6) 2015. PATIENT'S KNEE WOULD GO BACKWARDS WHEN SHE WOULD TRY TO STRAIGHTEN IT OUT AND ALMOST FELL A COUPLE OF TIMES. PATIENT WENT TO HER SURGEON AND WAS REVISED ON (B)(6) 2018. AFTER REVISION PATIENT WAS EXPERIENCING PAIN AND KNEE WAS FILLING UP WITH FLUID. PATIENT HAD PHYSICAL THERAPY AND WAS TOLD HER DEVICE WAS LOOSE. PATIENT WENT TO ANOTHER SURGEON AND WAS REVISED ON (B)(6) 2020 TO COMPETITOR IMPLANTS. PATIENT IS ONLY INQUIRING IF HER IMPLANTS ARE PART OF A RECALL.

  Patient problems: Injury; Pain

  MAUDE report 10294976 ↗
• InjuryJul 25, 2019Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO MECHANICAL LOOSENING OF RIGHT TOTAL KNEE REPLACEMENT.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8828205 ↗
• MalfunctionJul 8, 2019Manufacturing, Packaging or Shipping Problem; Packaging Problem; Manufacturing, Packaging or Shipping Problem; Packaging Problem

  PRIMARY PROCEDURE, RIGHT TKA. IT WAS REPORTED THAT WHEN THE OUTER BLISTER OF THE TIBIAL BASEPLATE WAS OPENED, THE TYVEK OF THE INNER BLISTER WAS OBSERVED TO BE ALREADY OPENED (NOT SEALED ALL THE WAY AROUND). DUE TO STERILITY CONCERNS, THE DEVICE WAS NOT USED. ANOTHER DEVICE WAS IMMEDIATELY AVAILABLE IN THE O.R. REP CONFIRMED THAT SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY AND THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8767502 ↗
• InjuryJul 2, 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 "PERIPROSTHETIC OSTEOLYSIS, RIGHT TOTAL KNEE REPLACEMENT".

  Patient problems: Injury; Osteolysis

  MAUDE report 8753508 ↗
• InjuryJul 2, 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 "PATELLOFEMORAL ARTHRITIS, POST PARTIAL TOTAL RIGHT KNEE REPLACEMENT."

  Patient problems: Arthritis; Injury

  MAUDE report 8753506 ↗
• InjuryJun 19, 2019Unstable; Malposition of Device; Unstable; Malposition of Device

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "FAILED LEFT TOTAL KNEE ARTHROPLASTY SECONDARY TO MALALIGNMENT AND INSTABILITY".

  Patient problems: Injury

  MAUDE report 8712657 ↗
• InjuryJan 21, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED: "PATIENT'S LEFT TIBIAL COMPONENT WAS REVISED DUE TO LOOSENING¿ALL TIBIAL COMPONENTS [12X50 STEM, SIZE 3 UNIVERSAL BASEPLATE, TWO AUGMENTS, 3X16 TS INSERT]¿WERE EXPLANTED AND REVISED TO TRIATHLON TS. TIBIAL SIDE AS A WHOLE WAS LOOSENED, NO SPECIFIC IMPLANT(S) CITED".

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8265296 ↗
• InjuryJul 10, 2018Loosening of Implant Not Related to Bone-Ingrowth; Migration; Loosening of Implant Not Related to Bone-Ingrowth; Migration

  IT WAS REPORTED THAT PATIENT'S LEFT KNEE WAS REVISED. AS REPORTED BY REP: "ASEPTIC LOOSENING". A SIZE 3 TIBIAL BASEPLATE AND 13MM PS INSERT WERE REVISED.

  Patient problems: Injury

  MAUDE report 7675870 ↗
• MalfunctionMar 29, 2017Device Contamination with Chemical or Other Material; Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED BY SALES REP, A HAIR WAS DISCOVERED IN THE INSIDE PACKAGING OF THE PRODUCT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6443396 ↗