Triathlon 5565-S-017Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613327026788), received between Mar 27, 2018 and Mar 11, 2022 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Osseointegration Problem” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMar 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD BILATERAL INDEX TKA (OUTSIDE OF CORS SCOPE (B)(6) 2011). HAD A PJI OF BOTH KNEES. UNDERGOES BILATERAL TKA REVISION ON (B)(6) 2020 WITH ALL COMPONENTS EXCHANGED, AND ANTIBIOTIC CEMENT LOADED FOR TREATMENT (STAGE 1 OF A 2-STAGE REVISION). PATIENT RETURNS FOR A LEFT PJI KNEE REVISION ON (B)(6) 2021. ALL COMPONENTS EXCHANGED (STAGE 2 OF A 2-STAGE REVISION. NOW THE PATIENT SUFFERS A FEMORAL PERIPROSTHETIC FRACTURE (B2) AND UNDERGOES REVISION OF FEMORAL, AND ROTATING COMPONENTS ON (B)(6) 2021.

  Patient problems: Bone Fracture(s); Fall; Limb Fracture

  MAUDE report 13729004 ↗
• InjuryFeb 2, 2021Material Erosion; Fracture; Material Erosion; Fracture

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED. THE 'FEMALE PORTION' OF THE BASEPLATE BROKE WHERE THE THREADED PORTION OF THE STEM IS. A PORTION OF THE THREADED PORTION BROKE OFF. A 17 X 100 TRIATHLON FLUTED STEM AND SIZE 5 TS BASEPLATE WERE REVISED.

  Patient problems: Ambulation or Postural Difficulties; Inflammation

  MAUDE report 11267988 ↗
• InjuryDec 19, 2019Osseointegration Problem; Osseointegration Problem

  THIS PI WAS CREATED BASED ON THE MEDICAL REVIEW PROVIDED FOR PI. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2011 DUE TO TIBIAL LOOSENING WHEREBY ALL TRIATHLON TS COMPONENTS EXCEPT THE PATELLA WERE REVISED TO COMPETITORS PRODUCTS.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 9495193 ↗
• 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 9109432 ↗
• InjuryJul 23, 2019Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO STEM LOOSENING. AS A RESULT, THE STEM WAS BUTTRESSING AGAINST THE CORTEX. THE FEMORAL COMPONENT, STEM AND LINER WERE REVISED. REP REPORTED HE MAY BE ABLE TO OBTAIN X-RAYS AND OPERATIVE REPORT, AND REPORTED THAT NO FURTHER INFORMATION WOULD BE AVAILABLE.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8816035 ↗
• InjuryAug 28, 2018Loss of Osseointegration; Loss of Osseointegration

  AS REPORTED: "THIS SUBJECT IS A PARTICIPANT IN THE TRIATHLON TS OUTCOMES STUDY. AN ADVERSE EVENT FORM WAS RECEIVED ON JULY 31, 2018 NOTING THAT THIS SUBJECT HAD A REVISION OF THE FEMORAL COMPONENT ON (B)(6) 2016 DUE TO PROGRESSIVE LOOSENING OF THE FEMORAL COMPONENT. NO OTHER PREVIOUS ADVERSE EVENT FORMS HAD BEEN SUBMITTED. THE 2-YEAR FOLLOW-UP VISIT ON (B)(6) 2016 NOTED THAT THE SUBJECT WAS EXPERIENCING MODERATE PAIN".

  Patient problems: Inadequate Osseointegration; Injury; Pain

  MAUDE report 7823143 ↗
• InjuryJul 18, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION IMPLANT SHEET. PATIENT WAS REVISED TO A TRIATHLON TS KNEE CONSTRUCT WITH 8 AUGMENTS, AND AN ASYMMETRIC PATELLA.

  Patient problems: Injury

  MAUDE report 7699479 ↗
• MalfunctionMar 27, 2018Packaging Problem; Packaging Problem

  THERE IS NOT A SECONDARY WHITE LAYER TO PEEL BACK ONCE ON STERILE FIELD. AROUND THE EDGES OF THE PACKAGE DOES NOT HAVE THE WHITE ADHESIVE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7373374 ↗