Triathlon 5515-F-402Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 07613327050370), received between Apr 24, 2017 and Aug 25, 2026 — classified as 18 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (7 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2026Loss of Osseointegration

  Second revision TKA. Reason for revision: loosening. Outcome: all implants removed, TS femur implanted, universal baseplate implanted, TS insert implanted.

  Patient problems: Inadequate Osseointegration

  MAUDE report 50435587 ↗
• InjuryJul 6, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: LEFT TKA CASE USING NAVIGATION. IMPLANT PLAN WAS CHANGED INTRAOPERATIVELY FROM FEMORAL CR TO PS. DUE TO PROLONGED SURGERY, THE TEAM WAS UNDER TIME PRESSURE. BOTH LEFT AND RIGHT IMPLANTS WERE STORED IN THE ANTEROOM. THE DOUBLE-CHECK WITH THE SURGEON PRIOR TO OPENING WAS SKIPPED. DURING VERBAL CONFIRMATION, ¿RIGHT¿ WAS READ ALOUD BUT NOT RECOGNIZED AS AN ERROR. THE IMPLANT WAS INSERTED WITHOUT RESISTANCE, AND THE SURGEON DID NOT NOTICE THE LATERALITY ERROR. THE ISSUE WAS NOT IDENTIFIED DURING X-RAY CONFIRMATION. THE ERROR WAS IDENTIFIED AFTERWARD WHEN THE IMPLANT LABEL (¿RIGHT¿) WAS CHECKED. ON THE SAME DAY, THE PATIENT UNDERWENT REOPERATION AND THE IMPLANT WAS REPLACED WITH THE CORRECT ONE. REVISION SURGERY WAS COMPLETED WITHOUT COMPLICATIONS.

  Patient problems: Insufficient Information

  MAUDE report 25725252 ↗
• InjuryDec 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT'S RIGHT KNEE WAS REVISED DUE TO PERIPROSTHETIC FRACTURE. A PS KNEE WAS CONVERTED TO A TRIATHLON HINGE KNEE. NO OTHER INFORMATION AVAILABLE DUE TO HOSPITAL POLICY. NOV 26, 2024- AS PER MEDICAL REVIEW: ON AP VIEW ONE CAN SEE THAT THERE IS A PERIPROSTHETIC FRACTURE JUST ABOVE THE FEMORAL PROSTHESIS. IT IS DISPLACED MEDIALLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 20830507 ↗
• InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PI IS FOR PAIN AFTER REVISION. PATIENT REPORTED A PRIMARY RIGHT KNEE SURGERY ON (B)(6) 2021 AND HAD A REVISION DUE TO INSTABILITY AND PAIN ON (B)(6) 2022. PATIENT STATED SHE DID NOT HAVE ANY IMPLANTS REMOVED OR REPLACED. PATIENT REPORTED CONTINUED PAIN AND ON (B)(6) 2023, LEG "WENT OUT" AND FEMUR BROKE. PATIENT NOTED SURGEON WANTS TO PERFORM ANOTHER SURGERY TO IMPLANT A ROD TO ADDRESS THE BROKEN FEMUR. PATIENT HAS NOT SCHEDULED ANOTHER REVISION. PATIENT NOTED SHE IS TAKING UP TO 5 OXYCODONE PILLS PER DAY FOR THE PAIN.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 18138515 ↗
• InjuryJun 15, 2022Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE SALES REP THAT SURGEON INFORMED THAT MEDIAL LAXITY AND HYPEREXTENSION WHEN PATIENT EXTEND HIS LEG DETECTED THROUGH CLINICAL FINDING UPON CLINIC APPOINTMENT. EXPLANTED DONE AND REPLACED WITH TS IMPLANTS ( REVISION SURGERY) THIS IS A FIRST REVISION SURGERY , THE PRIMARY SURGERY WAS DONE ON (B)(6) 2020. PATIENT OUTCOME ( AS OF (B)(6) 2022) : AS THE REVISION SURGERY JUST BEEN DONE, PATIENT IS RECOVERING WELL.

  Patient problems: Joint Laxity

  MAUDE report 14704704 ↗
• InjuryJun 17, 2021Fracture; Fracture

  AS REPORTED: "THE TRIATHLON IMPLANTS THAT WERE IN WERE BEING USED AS AN ANTIBIOTIC SPACER TO CLEAR UP A PREVIOUS INFECTION. AFTER THE SURGERY THE PATIENT FRACTURED THE DISTAL FEMUR. A NAIL WAS PLACED TO ADDRESS THE FRACTURE." SECOND STAGE REVISION WAS LATER PERFORMED TO REMOVE ALL HARDWARE AND IMPLANT A NEW KNEE. REP CONFIRMED THAT NO STAGE 1 IMPLANTS WERE REMOVED WHEN THE NAIL WAS PLACED. REP PROVIDED USAGE SHEETS AND CONFIRMED THAT OTHERWISE NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON. RIGHT KNEE.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 12014984 ↗
• InjuryMar 12, 2021Unstable; Unstable

  REMOVAL OF PRIMARY TRIATHLON IMPLANTS DUE TO INSTABILITY AND REPLACEMENT WITH TRIATHLON TS.

  Patient problems: Joint Laxity

  MAUDE report 11474119 ↗
• 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 10294980 ↗
• InjuryDec 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  BASED ON THE MEDICAL REVIEW FOR ANOTHER PI, ON (B)(6) 2014 A "1. RIGHT KNEE ARTHROSCOPY EXTENSIVE DEBRIDEMENT/ SYNOVECTOMY [...] "WAS PERFORMED FOR A POST-OPERATIVE DIAGNOSIS OF "1. RIGHT KNEE PAINFUL ... SYNOVITIS, ADHESIONS AND METAL DEBRIS " [...] THE OPERATIVE REPORT NOTES THE RIGHT KNEE "... WIDESPREAD GRAYISH DEBRIS ... COATING THE SYNOVIUM ... SOME ADHESIONS ... REMOVED WITH SHAVER ... WIDESPREAD METALLIC DEBRIS OVER THE ENTIRE SYNOVIUM ... REMOVED ... JOINT SURFACE LOOKED GOOD."

  Patient problems: Device Embedded In Tissue or Plaque; Injury; Pain; Synovitis

  MAUDE report 9520435 ↗
• InjuryOct 25, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  AFTER FEMORAL / TIBIA OSTEOTOMY, A FRACTURE OF THE EXTERNAL FEMORAL CONDYLE WAS CONFIRMED. IT WAS FIXED BY 4 SCREWS. REPLACED WITH CEMENT-FIXED IMPLANTS IN CONSIDERATION OF INITIAL FIXATION. BASED ON X-RAY, IT WAS CONFIRMED A FRACTURE LINE IN THE FEMORAL CONDYLE.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 9238826 ↗
• InjuryAug 28, 2019Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO PAIN AND INSTABILITY. THE FEMORAL COMPONENT AND PS INSERT WERE REVISED. THE REVISED IMPLANTS WERE NOT LOOSE, BROKEN, OR WORN. PATIENT WAS REVISED TO A FEMORAL COMPONENT WITH AUGMENTS AND STEM, AND A PS INSERT. REP REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury; Pain

  MAUDE report 8939506 ↗
• 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 8828106 ↗
• 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 8753581 ↗
• InjuryFeb 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  POSTOPERATIVE DIAGNOSIS: PATIENT UNDERWENT RIGHT KNEE REPLACEMENT (B)(6) 2013. PATIENT FELL DIRECTLY ON HER RIGHT KNEE. PATIENT UNDERWENT RIGHT TOTAL KNEE REVISION DUE TO PERIPROSTHETIC FEMUR FRACTURE (B2) RIGHT KNEE (B)(6) 2013. ONLY FEMUR AND LINER EXCHANGED.

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

  MAUDE report 8361402 ↗
• InjuryNov 5, 2018Unstable; Noise, Audible; Unstable; Noise, Audible

  PATIENT CALLED STATING THAT SHE HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2013. ON OR ABOUT (B)(6) 2013 SHE STARTED EXPERIENCING PAIN, SWELLING AND LOOSENING. UPDATE: PATIENT REPORTED THAT ONLY THE FEMORAL COMPONENT WAS REVISED. UPDATE: IT IS NOTED THAT A TRIATHLON INSERT COMPONENT WAS RETURNED TO STRYKER FOR EVALUATION, THEREFORE IT APPEARS THAT ONLY THE INSERT WAS REVISED. UPDATE: IT WAS REPORTED THROUGH MW5079852 "SEVERE SWELLING, PAIN, RIGHT KNEE CLICKING, INSTABILITY"

  Patient problems: Injury; Pain; Swelling

  MAUDE report 8039413 ↗
• InjuryOct 10, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH MEDWATCH MW5079432 "TOTAL RIGHT HIP KNEE ARTHROPLASTY CAUSED DEBILITATION PAIN, STIFFNESS, RANGE OF MOTION LOSS REQUIRING 2009 MANIPULATION AND REVISION SURGERY ON 2013. MEDICAL DEVICE PARTS CAUSED METAL POISONING AND SEVERE ALLERGIES, REPEATED F/U OFFICE VISITS WITH SURGEON REPORTING PAIN, STIFFNESS, LOSS OF RANGE OF MOTION AND METAL POISONING . ATTENDED YEARS OF PHYSICAL THERAPY AND DAILY INTAKE OF PRESCRIPTION MEDICATION TO CONTROL SYMPTOMS. LENGTH OF TIME BETWEEN INITIAL SURGERY AND REVISION SURGERY CREATED DEBILITATING MEDICAL ISSUES AND PERMANENT DISABILITY. MANIPULATION SURGERY FOR ARTHROFIBROSIS ON 2009 AND METAL POISONING" THIS PI IS FOR REVISION SURGERY IN (B)(6) 2013.

  Patient problems: Ambulation or Postural Difficulties; Inflammation; Injury; Loss of Range of Motion; Pain; Reaction

  MAUDE report 7954033 ↗
• InjuryOct 10, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH MEDWATCH MW 5079432 "TOTAL RIGHT HIP KNEE ARTHROPLASTY CAUSED DEBILITATION PAIN, STIFFNESS, RANGE OF MOTION LOSS REQUIRING 2009 MANIPULATION AND REVISION SURGERY ON 2013. MEDICAL DEVICE PARTS CAUSED METAL POISONING AND SEVERE ALLERGIES, REPEATED F/U OFFICE VISITS WITH SURGEON REPORTING PAIN, STIFFNESS, LOSS OF RANGE OF MOTION AND METAL POISONING . ATTENDED YEARS OF PHYSICAL THERAPY AND DAILY INTAKE OF PRESCRIPTION MEDICATION TO CONTROL SYMPTOMS. LENGTH OF TIME BETWEEN INITIAL SURGERY AND REVISION SURGERY CREATED DEBILITATING MEDICAL ISSUES AND PERMANENT DISABILITY. MANIPULATION SURGERY FOR ARTHROFIBROSIS ON 2009 AND METAL POISONING" THIS PI IS FOR MANIPULATION SURGERY FOR ARTHROFIBROSIS ON 2009.

  Patient problems: Ambulation or Postural Difficulties; Inflammation; Injury; Loss of Range of Motion; Pain; Reaction

  MAUDE report 7954023 ↗
• MalfunctionMar 14, 2018Packaging Problem; Packaging Problem

  A TINY HOLE WAS NOTICED BY THE HOSPITAL STAFF ON THE INNER PACKAGING OF A SIZE 4 RIGHT PS FEMUR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7339154 ↗
• InjuryApr 24, 2017Delivered as Unsterile Product; Device Contamination with Chemical or Other Material; Packaging Problem; Device Contamination with Chemical or Other Material; Packaging Problem

  NURSE OPENED IMPLANT BOX AND NOTICED HAIR ON THE INSIDE OF BOX. IMPLANT WAS NEVER OPENED ON TO THE STERILE FIELD.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 6517193 ↗