Triathlon 5515-F-401Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07613327050387), received between Apr 3, 2017 and Apr 21, 2025 — classified as 10 injuries, 1 malfunction.

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

• InjuryApr 21, 2025Malposition of Device; Malposition of Device

  AS REPORTED: "REV LTKA- FOR LOOSE TIBIA AND MAL ALIGNMENT." A PS KNEE WAS CONVERTED TO A TS KNEE WITH STEMS AND AUGMENTS. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 21875176 ↗
• InjuryAug 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A PRIMARY LEFT TKA ON (B)(6) 2022. THE PATIENT FELL AND HAD A PERIPROSTHETIC FRACTURE AROUND THE FEMUR B2. UNDERWENT REVISION FOR ALL COMPONENTS EXCEPT THE PATELLA. TIBIAL BASEPLATE WAS REVISED DUE TO CHANGE THE CONSTRUCT.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 17438308 ↗
• InjuryOct 20, 2021Malposition of Device; Malposition of Device

  SURGEON NOT HAPPY WITH OUTCOME OF SURGERY. PT STARTED IN VALGUS ENDED UP IN VARUS.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 12665211 ↗
• InjuryApr 27, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO PAIN AND SWELLING, AND DISLOCATION OF THE PATIENT'S RESURFACED PATELLA. THE TIBIAL COMPONENT AND INSERT WERE REVISED. NO INTRA-OPERATIVE FINDINGS OR SURGEON OPINION WAS REPORTED TO THE REP AS TO WHY THE TIBIA WAS REVISED. REP PROVIDED THE REVISION USAGE SHEET, CONFIRMED THERE WERE NO ALLEGATIONS AGAINST THE REVISED INSERT, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 11730569 ↗
• InjuryOct 23, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO PAIN AND ASEPTIC LOOSENING (IT WAS NOT REPORTED TO THE REP WHICH SPECIFIC DEVICE(S) LOOSENED). A FEMORAL COMPONENT, BASEPLATE AND INSERT WERE REVISED TO A TS KNEE CONSTRUCT WITH FEMORAL AND TIBIAL AUGMENTS, AND STEMS. REP PROVIDED THE PRIMARY AND REVISION USAGE SHEETS AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 10725078 ↗
• InjurySep 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT FELL RECENTLY AND HAD DISTAL FEMUR FRACTURE FROM ORIGINAL SURGERY DATE OF (B)(6) 2018. TODAY'S SURGERY IS TO REMOVE ORIGINALLY PLACED LEFT TOTAL KNEE AND REVISE TO GMRS DISTAL FEMORAL REPLACEMENT

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 9123618 ↗
• InjurySep 5, 2019Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING LEFT TOTAL KNEE REPLACEMENT AND MORBID OBESITY.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8964583 ↗
• InjuryJul 2, 2019Unstable; Unstable

  THIS PI IS FOR THE LEFT KNEE IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "UNSTABLE LEFT TOTAL KNEE ARTHROPLASTY, ALL COMPONENTS." UPDATE (B)(6) 2019: AS PER MEDICAL REVIEW DATED (B)(6) 2019 "COMPONENT MALPOSITION OF TRIATHLON PS KNEE COMPONENTS WITH A ¿SIGNIFICANTLY ELEVATED JOINT LINE¿ HAS CONTRIBUTED TO GROSS INSTABILITY OF THE ARTHROPLASTY REQUIRING EXCHANGE OF ALL KNEE DEVICES AFTER 5-YEARS".

  Patient problems: Injury

  MAUDE report 8753913 ↗
• InjuryMar 14, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT IS REPORTED BY COUNSEL FOR CLAIMANT PATIENT THAT CLAIMANT RECEIVED A LTKA PERFORMED BY DR. (B)(6) AT THE (B)(6) CLINIC IN (B)(6) ON (B)(6) 2017. A (B)(6) UNIT WAS USED DURING THE SURGERY. TWO WEEKS FOLLOWING HER LTKA, THE CLAIMANT EXPERIENCED A FEMUR FRACTURE. ACCORDING TO COUNSEL, THE FRACTURE WAS DUE TO A WEAKNESS IN THE FEMUR RESULTING FROM THE PINHOLE USED FOR (B)(6) COMPUTER NAVIGATION. THE CLAIMANT REQUIRED AN INTERNAL FIXATION ON (B)(6) 2017 TO REPAIR THE FRACTURE AND EXPERIENCED SUBSEQUENT COMPLICATIONS.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 7338787 ↗
• MalfunctionFeb 16, 2018Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  AS REPORTED: "THIS HAS HAPPENED IN THE PAST. I'VE SUGGESTED PACKAGING BE CHANGED SO THE FEMUR DOES NOT 'STICK' TO THE PLASTIC MATERIAL MAKING IT VERY DIFFICULT FOR STAFF TO PASS IT OFF STERILE AND NOT DROPPING IT BY HAVING TO PULL IT VERY HARD OUT OF PACKAGE...".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7276912 ↗
• InjuryApr 3, 2017Fracture; Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT'S TOTAL KNEE REPLACEMENT WAS REVISED DUE TO A FALL THAT CAUSED A PERIPROSTHETIC FRACTURE AROUND THE DISTAL FEMORAL COMPONENT. A DISTAL FEMORAL ROTATING HINGE TKA WAS PERFORMED TO TREAT THE PROBLEM.

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

  MAUDE report 6452870 ↗