Triathlon 5512-F-701Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327026641), received between Sep 27, 2018 and Feb 25, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• InjuryFeb 25, 2026Loss of Osseointegration; Detachment of Device or Device Component

  THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO THE STEM BECOMING LOOSE/ UNTHREADING FROM THE FEMORAL COMPONENT (REP CONFIRMED THREADS/ IMPLANTS WERE NOT BROKEN). THE FEMORAL COMPONENT, STEM, AND LINER WERE REVISED. REP CONFIRMED THAT THERE WERE NO ALLEGATIONS AGAINST THE REVISED LINER, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration; Insufficient Information

  MAUDE report 24443726 ↗
• InjuryJul 25, 2019Unstable; Unstable

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "UNSTABLE, PAINFUL LEFT TOTAL KNEE ARTHROPLASTY."

  Patient problems: Injury; Pain

  MAUDE report 8827732 ↗
• InjurySep 27, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT'S LEFT KNEE WAS REVISED DUE TO DISLOCATION (FEMORAL COMPONENT WAS SITTING ANTERIOR TO TIBIA). SURGEON REPORTED DISLOCATION WAS DUE TO PATIENT'S NEUROLOGICAL CONDITION WHICH LIMITS AMBULATION TO CRAWLING AROUND, AND THAT THERE ARE NO ALLEGATIONS AGAINST ANY STRYKER DEVICES. PATIENT WAS REVISED TO AN MRH KNEE.

  Patient problems: Ambulation or Postural Difficulties; Injury; Joint Dislocation; Neurological Deficit/Dysfunction

  MAUDE report 7916053 ↗