Triathlon 5515-F-502Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 07613327050400), received between Mar 29, 2017 and Apr 25, 2025 — classified as 14 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Unstable” (5 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryApr 25, 2025Unstable; Unstable

  AS REPORTED: "PATIENT IS STATUS POST REV RTKA COMPLETED TODAY DUE TO INSTABILITY. NO ADDITIONAL DETAILS WERE PROVIDED." A PS FEMORAL COMPONENT AND INSERT WERE REVISED TO A TS FEMORAL COMPONENT AND INSERT WITH STEM AND AUGMENTS.

  Patient problems: Joint Laxity

  MAUDE report 21914624 ↗
• InjuryDec 19, 2024Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem; Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO PAIN AND SUSPECTED FEMORAL LOOSENING (SURGEON HAD REPORTED LUCENCY ANTERIORLY OF THE FEMUR). INTRA-OPERATIVELY, IT WAS NOTED THE FEMUR WAS DIFFICULT TO REMOVE. SURGEON'S ORIGINAL PLAN WAS TO REVISE THE FEMUR, BUT DECIDED TO CONVERT THE ENTIRE PS KNEE TO A TS KNEE WITH STEMS AND AUGMENTS. THERE WERE NO ALLEGATIONS AGAINST THE REVISED INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 20978986 ↗
• InjuryJun 11, 2024Loss of Osseointegration; Osseointegration Problem; Loss of Osseointegration; Osseointegration Problem

  PT DEVELOPED PAINFUL SWOLLEN KNEE. SURGEON BELIEVES DUE TO ASCEPTIC LOOSENING. BOOKED FOR REVISION OF FEMORAL COMPONENT ON (B)(6) 2024. ISSUE NOTICED: IDENTIFIED ON A CONSULT VISIT TO SURGEONS ROOMS.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 19510042 ↗
• 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 16928894 ↗
• InjuryOct 21, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO DISLOCATION OF THE FEMORAL COMPONENT OFF OF THE BACK OF THE INSERT. THE INSERT WAS REVISED. REP REPORTED THAT HE CAN PROVIDE USAGE, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Dislocation

  MAUDE report 12673523 ↗
• InjuryApr 23, 2021Unstable; Noise, Audible; Unstable; Noise, Audible

  THE PATIENT REPORTED SHE HAD BILATERAL TKA DONE ON (B)(6) 2018 RIGHT AND (B)(6) 2018 LEFT. PATIENT STARTED TO EXPERIENCE PAIN ON HER RIGHT KNEE RIGHT AFTER SURGERY. PATIENT STATED IS HARD FOR HER TO WALK AND NEEDS SOMETHING TO HOLD ON TO. SHE IS ALSO EXPERIENCING CLICKING. PATIENT WOULD LIKE TO KNOW IF HER IMPLANTS ARE PART OF A RECALL. UPDATED ON 01APR2021 BASED ON MEDICAL REVIEW: "UNTIL (B)(6) 2020 ON EXAM, HER RIGHT ROM WAS 0-100°, WITH 1MM POSITIVE TO VARUS STRESS AND STABLE TO VALGUS STRESS."

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Loss of Range of Motion; Pain

  MAUDE report 11715373 ↗
• InjuryJun 29, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS PI IS FOR THE REVISION OF THE PATIENT'S RIGHT KNEE ON (B)(6) 2020. AS REPORTED: "DOCTOR STATED 'DIAGNOSIS IS ARTHROFIBROSIS.' GOT LOST TO FOLLOWUP FOR 4 YEARS, AND DEVELOPED FLEXION CONTRACTURE. PATIENT WASHED OUT (B)(6) 2014, AND HAD POLY INSERT EXCHANGED. RIGHT SIDE. NOTHING WAS LOOSE OR BROKEN. GRAHM STAIN WAS NEGATIVE [FOR INFECTION]. THIS WILL BE ALL INFORMATION DUE TO HOSPITAL POLICIES." SPOKE TO REP. THE PATIENT'S PS KNEE CONSTRUCT WAS REVISED TO A TS KNEE ON (B)(6) 2020 DUE TO THE REPORTED FLEXION CONTRACTURE.

  Patient problems: Injury; Muscular Rigidity

  MAUDE report 10206161 ↗
• InjuryMay 19, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED. ORIGINALLY, AN IRRIGATION AND DEBRIDEMENT WITH WOUND RE-CLOSURE WAS SCHEDULED DUE TO THE PATIENT FALLING AND OPENING THE SURGICAL WOUND (NO ALLEGATION OF INFECTION). HOWEVER, DUE TO EXTENSION LAG (PATIENT UNABLE TO FULLY STRAIGHTEN HIS LEG), THE SURGEON PERFORMED A SOFT TISSUE RELEASE AND DECIDED THAT REVISION THE FEMORAL COMPONENT AND INSERT, WITH ADDITIONAL FEMORAL BONE RESECTION WAS REQUIRED. REP PROVIDED PRIMARY AND REVISION USAGE, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Injury

  MAUDE report 10072449 ↗
• InjurySep 5, 2019Unstable; Unstable

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

  Patient problems: Injury; Joint Laxity

  MAUDE report 8964645 ↗
• InjuryApr 11, 2019Unstable; Unstable

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

  Patient problems: Injury

  MAUDE report 8504317 ↗
• InjuryFeb 22, 2019Unstable; Unstable

  POSTOPERATIVE DIAGNOSIS: PATIENT UNDERWENT PRIMARY RIGHT KNEE REPLACEMENT (B)(6) 2018. PATIENT RETURNED TO UNDERGO THE REVISION DUE TO PATELLAR INSTABILITY AND PAIN ON (B)(6) 2018 WITH A HINGE PROSTHESIS. ALL COMPONENTS EXCHANGED.

  Patient problems: Injury; Pain

  MAUDE report 8361898 ↗
• InjuryJul 10, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT UNDERWENT PRIMARY TKA (B)(6) 2018 AND RETURNED TO ED COMPLAINING OF PAIN AND DYSFUNCTION. PATIENT UNDERWENT REVISION FOR DISTAL FEMUR FRACTURE.

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

  MAUDE report 7675459 ↗
• MalfunctionApr 24, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED: "WHEN IMPLANT OPENED THERE WAS A FOREIGN BODY FOUND IN THE SCREW HOLE OF POSTERIOR FEMORAL CONDYLE OF COMPONENT". OPERATIVE SIDE IS RIGHT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7454583 ↗
• InjuryFeb 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  REVISION OF PRIMARY RIGHT TOTAL KNEE POST PERI PROSTHETIC FRACTURE WITH DISTAL FEMORAL REPLACEMENT WAS PERFORMED.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 7277006 ↗
• MalfunctionNov 14, 2017Difficult to Remove; Packaging Problem; Difficult to Remove; Packaging Problem

  IT WAS REPORTED THAT DURING A PROCEDURE ON PATIENT'S RIGHT KNEE, THE IMPLANT COULD NOT BE REMOVED FROM THE PACKAGING AS IT WAS WEDGED IN TOO TIGHTLY. A REPLACEMENT IMPLANT WAS IMMEDIATELY AVAILABLE FOR USE. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7027658 ↗
• InjuryJul 31, 2017Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT A SURGEON CEMENTED AND REMOVED A RIGHT FEMORAL COMPONENT IN PATIENT'S LEFT KNEE. REVISION AND REPLACEMENT REQUIRED A 5MM DISTAL, MEDIAL AUGMENT ON THE NEW PS FEMUR. THE REVISION WAS DUE TO THE FACT THAT A RIGHT FEMORAL COMPONENT WAS CEMENTED ONTO A LEFT FEMUR. IT WAS REMOVED AND WHEN REMOVED SOME BONE LOSS REQUIRED A 5MM AUGMENT. THERE WERE NO EXTRAORDINARY CIRCUMSTANCES PRESENT IN THE OR DURING THE PROCEDURE. IT WAS A COLLECTIVE OVERSIGHT BY THE ENTIRE STAFF, SALES REP, AND SURGEON.

  Patient problems: Injury

  MAUDE report 6755327 ↗
• MalfunctionJun 20, 2017Packaging Problem; Difficult to Open or Remove Packaging Material; Packaging Problem

  REPORTED THE PACKAGING WAS NOT ALLOWING THE INNER PACKING OF THE FEMORAL COMPONENT TO BE REMOVED FROM THE OUTER PACKAGING.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 6653751 ↗
• MalfunctionMar 29, 2017Device Contamination with Chemical or Other Material; Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT UPON OPENING THE IMPLANT, A STAIN-LIKE SUBSTANCE WAS PRESENT ON THE UNIT.

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

  MAUDE report 6443072 ↗