Triathlon 5510-F-801Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327040340), received between Jan 4, 2017 and Mar 12, 2020 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Slipped” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 12, 2020Packaging Problem; Packaging Problem

  TRIATHLON FEMORAL IMPLANT BOX WAS OPENED, AND THE PLASTIC PACKAGING SEAL INSIDE WAS BROKEN. THE PRODUCT WAS NOT USED, AND ANOTHER THAT WAS AVAILABLE WAS USED IN ITS PLACE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9827486 ↗
• InjuryFeb 26, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO A FRACTURE OF THE IMPLANTED FEMORAL COMPONENT. POSSIBLE CAUSE OR CONTRIBUTOR FOR DEVICE FRACTURE WAS NOT REPORTED TO THE REP. THE PATIENT'S FEMUR DID NOT FRACTURE. AS A RESULT OF THE DEVICE FRACTURE, THE PATIENT'S KNEE CONSTRUCT BECAME MIS-ALIGNED, CAUSING WEAR OF THE PATELLAR COMPONENT AND LOOSENING OF THE TIBIAL BASEPLATE. THE PATIENT'S ENTIRE KNEE CONSTRUCT WAS REVISED. REP CONFIRMED THAT THERE ARE NO ALLEGATIONS AGAINST THE REVISED INSERT. REP ALSO CONFIRMED THAT HE HAS SOME PICTURES PERTAINING TO THE EVENT, AND THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Injury

  MAUDE report 9757905 ↗
• InjuryJan 4, 2017Use of Device Problem; Unintended System Motion; Device Slipped; Use of Device Problem

  PER PATIENT, HIS LEFT KNEE PRIMARY SURGERY WAS DONE IN APPROXIMATELY (B)(6) 2015. HE WOULD WALK AND FALL. THE SURGEON STATED THAT THERE WAS TOO MUCH MOVEMENT IN THE IMPLANT. HE INDICATED THAT IT WAS LOOSE AND REVISED THE PATIENT ON (B)(6) 2016. THIS PI IS FOR THE REVISION. PRIMARY SURGERY HAD STRYKER PRODUCTS AND REVISION SURGERY HAD STRYKER PRODUCTS.

  Patient problems: Fall; Inadequate Osseointegration; Injury

  MAUDE report 6223709 ↗