Triathlon 5515-F-202Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327040715), received between Nov 27, 2019 and Oct 13, 2024 — classified as 6 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryOct 13, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT HAD A RIGHT KNEE FEMORAL FRACTURE SUSTAINED IN A FALL. NO IMPLANTS WERE REMOVED, BUT A RETROGRADE NAIL (MANUFACTURER UNKNOWN) WAS IMPLANTED ON (B)(6) 2019. UPON FOLLOW-UP ON (B)(6) 2023, PATIENT REPORTED 'SOME LIMITATION IN RANGE OF MOTION...DOES HAVE SOME DISCOMFORT IN THE LATERAL KNEE WHEN SHE IS STANDING UP FROM A SEATED POSITION. AS SOON AS SHE STARTS AMBULATING THE PAIN GOES AWAY.'

  Patient problems: Loss of Range of Motion

  MAUDE report 20436449 ↗
• InjuryOct 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A RIGHT KNEE FEMORAL FRACTURE SUSTAINED IN A FALL. NO IMPLANTS WERE REMOVED, BUT A RETROGRADE NAIL (MANUFACTURER UNKNOWN) WAS IMPLANTED.

  Patient problems: Bone Fracture(s); Fall; Loss of Range of Motion

  MAUDE report 20436152 ↗
• InjuryMay 9, 2022Unstable; Unstable

  PATIENT CALLED AND IS INQUIRING ABOUT RECALL FOR HER RIGHT KNEE SURGERY ON (B)(6) 2016. UPDATE (B)(6) 2022: PATIENT IS EXPERIENCING INSTABILITY. SHE HAS SEEN THREE DIFFERENT SURGEONS AND HAS UPCOMING REVISION SURGERY IN MID JUNE. PATIENT WOULD LIKE TO KNOW WHAT IMPLANTS SHE CAN USE IN HER REVISION FOR A BETTER OUTCOME.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 14342921 ↗
• InjuryAug 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO FAILURE OF FIXATION OF AN INTRA-OPERATIVE FEMUR FRACTURE THAT OCCURRED ON (B)(6) 2021. THE PATIENT WAS REVISED TO A DISTAL FEMORAL REPLACEMENT. REP PROVIDED PRIMARY AND REVISION USAGE SHEETS AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Bone Fracture(s)

  MAUDE report 12350400 ↗
• InjuryAug 9, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  DURING A RIGHT MAKO TKA, THE PATIENT'S FEMUR FRACTURED WHILE PLACING PS FEMORAL COMPONENT. SURGEON DECIDED TRIED TO USE A TS FEMORAL COMPONENT WITH A STEM TO REDUCE THE FRACTURE. THAT DID NOT WORK, SO THE SURGEON DECIDED TO CEMENT IN A NEW PS FEMORAL COMPONENT AND USE CORTICAL SCREWS (MANUFACTURER UNKNOWN) TO ADDRESS THE FRACTURE. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE ROBOT. REP PROVIDED THE USAGE SHEET, WHICH SHOWS THE WASTED IMPLANTS. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Bone Fracture(s)

  MAUDE report 12293476 ↗
• InjuryNov 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  DURING TKA SURGERY, LATERAL CONDYLE FRACTURE WAS FOUND AFTER PS BOX CUT. THE PROCEDURE WAS PROGRESSED AS IT IS, ALIGNMENT OF THE FEMORAL COMPONENT SHIFTED AND THE TIBIA BECAME VARUS.

  Patient problems: Bone Fracture(s)

  MAUDE report 9385368 ↗