Triathlon 5515-F-602Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07613327050424), received between Apr 6, 2018 and Nov 15, 2024 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of Osseointegration” (4 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryNov 15, 2024Loss of Osseointegration; Loss of Osseointegration

  THIS PI IS FOR THE RIGHT KNEE. AS REPORTED: "DR. IS ASKING FOR US TO DOCUMENT AN INSTANCE OF ASEPTIC LOOSENING FOR A PATIENT SHE OPERATED ON (B)(6) 2022. THE PATIENT HAD BILATERAL TKA AND IS NOW BEING REVISED ON BOTH SIDES FOR LOOSENING. SHE HAD SHARED THE IMPLANT INFORMATION AND ASKED THAT WE CHECK THE LOT NUMBERS FOR ANY RECALLS." NONE OF THE REPORTED IMPLANTS WERE SUBJECT TO RECALL.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20693294 ↗
• InjuryFeb 23, 2024Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO ASEPTIC LOOSENING OF THE FEMORAL COMPONENT. A PS FEMUR AND INSERT WERE REVISED TO A TS FEMUR AND INSERT WITH STEM AND AUGMENTS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18769652 ↗
• InjuryJan 14, 2022Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO FEMORAL LOOSENING. INTRA-OPERATIVELY, IT WAS NOTED THAT THE CEMENT (2 DOSES OF THE SAME LOT WERE MIXED TOGETHER) WAS BONDED TO THE IMPLANT BUT NOT THE PATIENT'S BONE. HOWEVER, THE SAME CEMENT WAS USED FOR THE TIBIA AND WAS WELL-FIXED TO BOTH IMPLANT AND BONE. THE FEMORAL COMPONENT AND INSERT WERE REVISED TO A TS FEMUR WITH STEM AND NEW INSERT. REP CONFIRMED THERE ARE 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 13257134 ↗
• InjuryApr 24, 2020Unstable; Unstable

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "FAILED RIGHT TOTAL KNEE ARTHROPLASTY". UPDATE: BASED ON THE MEDICAL REVIEW DATED (B)(6) 2020 INITIAL SUBCLINICAL INSTABILITY HAS INCREASED WITH TIME UNDER DAILY LOAD FURTHER AND MAGNIFIED BY PATIENT'S OBESITY RESULTING IN CLINICAL INSTABILITY ULTIMATELY REQUIRING REVISION SURGERY WITH INCREASE IN CONSTRAINT ACROSS THE KNEE THROUGH USE OF TRIATHLON TS DEVICES.

  Patient problems: Ambulation or Postural Difficulties; Injury; Pain

  MAUDE report 9997180 ↗
• InjuryJun 20, 2019Unstable; Unstable

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "GLOBAL INSTABILITY OF RIGHT KNEE FOLLOWING TOTAL KNEE ARTHROPLASTY OF RIGHT KNEE WITH CHRONIC EFFUSIONS".

  Patient problems: Injury

  MAUDE report 8716910 ↗
• InjuryApr 26, 2019Noise, Audible; Noise, Audible

  THIS PI IS FOR CLICKING NOISE AND PAIN AFTER REVISION. AS PER OP REPORT, PATIENT IS EXPERIENCING PAIN AND CLICKING NOISE 2 WEEKS POST REVISION.

  Patient problems: Injury; Pain

  MAUDE report 8556838 ↗
• InjuryMar 16, 2019Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "RIGHT KNEE OSTEOARTHRITIS AND RIGHT KNEE TOTAL ARTHROPLASTY FAILURE OR LOOSENING."

  Patient problems: Arthritis; Inadequate Osseointegration; Injury

  MAUDE report 8426529 ↗
• InjuryDec 10, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH MEDWATCH (MW5080901) "HAVE STRYKER TOTAL KNEE REPLACEMENT IN 2015. STILL KNEE HURTS AND SWELLING. LUCENCY BETWEEN FEMORAL COMPONENT AND THE FEMORAL ON THE ANTERIOR ASPECT, RIGHT KNEE IS STILL GIVING OUT. "HALE" OSTEOPOROSIS, STILL WEARING KNEE BRACE, CANE AND WALKER. ALSO, THERE IS A SLIGHT LATERAL TILT TO THE PATELLA, STRYKER TOTAL KNEE REPLACEMENT WILL NOT STOP HURTING, WILL NOT STOP SWELLING, PAIN IS A LOT. DOCTOR SAID I NEED TOTAL KNEE REPLACEMENT."

  Patient problems: Pain; Swelling

  MAUDE report 8148721 ↗
• InjuryJul 27, 2018Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT PATIENT'S RIGHT KNEE WAS REVISED DUE TO ASEPTIC LOOSENING AND PAIN.

  Patient problems: Inadequate Osseointegration; Injury; Pain

  MAUDE report 7725704 ↗
• InjuryJul 19, 2018Unstable; Insufficient Device Problem Information; Unstable; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S RIGHT KNEE WAS REVISED DUE TO A SURGICAL ERROR RESULTING IN INSTABILITY. REP REPORTED THAT THE GAPS WERE NOT BALANCED AND THAT THE KNEE WAS STABLE IN EXTENSION BUT LOOSE IN FLEXION. PATIENT WAS REVISED TO A TRIATHLON TS CONSTRUCT WITH A LARGER SIZE 7 FEMUR. REP REPORTED THAT X-RAYS, MEDICAL RECORDS, AND FURTHER INFORMATION ARE NOT AVAILABLE DUE TO HOSPITAL POLICY.

  Patient problems: Injury; Joint Laxity

  MAUDE report 7704729 ↗
• MalfunctionApr 6, 2018Off-Label Use; Off-Label Use

  THE CUSTOMER REPORTED IMPLANTATION OF A RIGHT TRIATHLON PS FEMORAL COMPONENT INTO A LEFT KNEE ON (B)(6) 2017.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7402657 ↗