Triathlon 5515-F-302Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07613327050363), received between Sep 14, 2017 and Mar 27, 2023 — classified as 10 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMar 27, 2023Fracture; Malposition of Device; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem; Fracture; Malposition of Device; Adverse Event Without Identified Device or Use Problem; Osseointegration Problem

  DAUGHTER OF PATIENT REPORTED THAT WITHIN A YEAR OF PRIMARY RIGHT KNEE SURGERY, (B)(6) 2019, HER MOTHER EXPERIENCED IMPLANT "FAILURE" AND WITHIN TWO YEARS REQUIRED A REVISION, (B)(6) 2021. PATIENT EXPERIENCED A FEMUR FRACTURE DURING THE REVISION WHICH REQUIRED A "ROD" TO BE PLACED. PATIENT CURRENTLY EXPERIENCES RIGHT KNEE STIFFNESS AND SWELLING. PATIENT DID EXPERIENCE PAIN AT/AROUND HER THIRD POST OP VISIT WHICH SHE REPORTED TO HER SURGEON AT THE TIME. PATIENT CONFIRMED THAT SHE WAS ACTIVELY DOING PHYSICAL THERAPY AT THE TIME OF THE ONSET OF PAIN. DAUGHTER IS INQUIRING IF IMPLANTS ARE SUBJECT TO A RECALL. UPDATE 11/14/2023: PER MEDICAL REVIEW ADDENDUM, THE SURGEON FOUND MALROTATION OF BOTH FEMUR AND TIBIA CONTRIBUTING TO THE PATIENT¿S SYMPTOMS, AS WELL AS MOST LIKELY LOOSENING OF THE FEMORAL COMPONENT BASED UPON EASE OF REMOVAL. UPDATE: 11/27/2023: PER MED REVIEW, THE SURGEON STATES THERE WAS NOTICE OF PART OF THE CEMENT MANTLE BEING BROKEN OFF AT APPROXIMATELY 3 MONTHS AFTER THE SURGERY.

  Patient problems: Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 16620472 ↗
• InjurySep 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED A PRIMARY RIGHT KNEE IN (B)(6) 2021 AND A REVISION DUE TO "POSTERIOR DISLOCATION" ON (B)(6) 2022. PATIENT WOULD LIKE TO KNOW IF IMPLANTS ARE SUBJECT TO A RECALL.

  Patient problems: Joint Dislocation

  MAUDE report 15455798 ↗
• InjuryFeb 4, 2022Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING A PRIMARY KNEE PROCEDURE, A RIGHT PS FEMORAL COMPONENT WAS IMPLANTED INTO THE PATIENT'S LEFT KNEE. THE PATIENT HAS NOT BEEN REVISED AT THE TIME OF REPORT, AND THE TREATMENT PLAN FOR THE PATIENT WAS NOT REPORTED TO THE REP. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13450309 ↗
• InjuryMar 30, 2020Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO FLEXION INSTABILITY. A PS FEMUR AND INSERT WERE REVISED TO A TS FEMUR WITH AUGMENTS AND A STEM, AND A TS INSERT. REP PROVIDED THE PRIMARY USAGE SHEET AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON. REP PROVIDED THE PRIMARY USAGE SHEET AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury

  MAUDE report 9898006 ↗
• InjuryNov 21, 2019Osseointegration Problem; Osseointegration Problem

  THIS PI IS FOR RIGHT KNEE. IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO A FAILED RIGHT TOTAL KNEE ARTHROPLASTY. UPDATE (B)(6) 2019: MEDICAL REVIEW STATED THE FOLLOWING: RIGHT KNEE REVISION SURGERY WAS PERFORMED ON (B)(6) 2018. DURING REVISION, BOTH TIBIAL BASEPLATE AND FEMORAL COMPONENT APPEARED LOOSE AND COULD BE REMOVED WITHOUT UNDUE BONE DAMAGE. THE PATELLAR COMPONENT WAS INTACT WITHOUT ISSUES AND WAS AS SUCH RETAINED. CONCLUSION OF ASSESSMENT: THERE IS SOME INFORMATION AVAILABLE IN THE MEDICAL RECORDS TO SUGGEST THAT COMPONENT MALPOSITION HAS PLAYED A RELEVANT ROLE IN THE FAILURE MODE OF THIS TRIATHLON PS ARTHROPLASTY DUE TO FIXATION FAILURE. LACK OF X-RAY AVAILABILITY AT THIS TIME PREVENTS TO ESTABLISH THIS WITH MORE CERTAINTY.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 9355096 ↗
• InjuryJul 24, 2019Osseointegration Problem; Osseointegration Problem

  THIS PI IS FOR THE REVISION DUE TO LOOSE COMPONENTS ON (B)(6) 2019. POSTOPERATIVE DIAGNOSIS: PATIENT UNDERWENT RIGHT TOTAL KNEE REPLACEMENT (B)(6) 2013. PATIENT HAD RIGHT KNEE INFECTION, UNDERWENT RIGHT KNEE IRRIGATION, DEBRIDEMENT, AND EXCHANGE OF POLYETHYLENE ON (B)(6) 2015. REPORTED IN CORS PER 1271KNEE. THE PATIENT HAD GROSSLY LOOSE COMPONENTS, UNDERWENT RIGHT TOTAL KNEE SINGLE STAGE REVISION WITH LOOSE FEMORAL AND TIBIAL COMPONENTS (B)(6) 2019.

  Patient problems: Inadequate Osseointegration; Injury; Unspecified Infection

  MAUDE report 8821968 ↗
• InjuryJun 11, 2019Osseointegration Problem; Osseointegration Problem

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

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8687088 ↗
• InjuryApr 24, 2019Unstable; Unstable

  PATIENT CALLED STATING SHE HAD A RIGHT KNEE REPLACEMENT DONE ON (B)(6) 2013. SHE HAS BEEN EXPERIENCING PAIN, DISCOMFORT AND FEELS HER KNEE IS NOT STABLE. PATIENT WILL LIKE TO KNOW IF HER IMPLANTS WERE INVOLVED IN A RECALL. PATIENT IS SCHEDULED TO HAVE A REVISION ON (B)(6) 2019.

  Patient problems: Pain

  MAUDE report 8546688 ↗
• InjuryJul 25, 2018Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT PATIENT'S LEFT KNEE WAS REVISED DUE TO PAIN. INTRA-OPERATIVELY, THE FEMORAL COMPONENT WAS FOUND TO BE LOOSE. THE FEMORAL COMPONENT AND INSERT WERE REVISED TO A TS CONSTRUCT (BASEPLATE WAS NOT REVISED).

  Patient problems: Inadequate Osseointegration; Injury; Pain

  MAUDE report 7718975 ↗
• InjurySep 14, 2017Off-Label Use; Off-Label Use

  A SALES REPRESENTATIVE UNINTENTIONALLY PROVIDED SURGEON WITH A CEMENTED PS FEMUR WHEN HE REQUESTED A PRESSFIT PS FEMUR. NO ONE IN THE O.R. CAUGHT THE MISTAKE, SO THE CEMENTED FEMUR WAS IMPLANTED WITHOUT CEMENT IN THE SAME MANNER A PRESSFIT KNEE WOULD BE IMPLANTED. THE SALES REPRESENTATIVE NOTICED THE ERROR ABOUT 3 HOURS POST-OP WHEN PRICING DID NOT MATCH WITH THE HOSPITAL WHEN OBTAINING P.O. SURGEON WAS NOTIFIED. SURGEON SPOKE WITH PATIENT AND EXPLAINED THE ERROR. INCORRECT FEMUR WAS REMOVED ON (B)(6) 2017 AND REPLACED WITH A PRESSFIT PS FEMUR. A NEW PS POLY INSERT WAS EXCHANGED AS WELL.

  Patient problems: Injury

  MAUDE report 6865619 ↗