Triathlon 5516-F-601Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327040869), received between Mar 31, 2020 and Mar 31, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  A SIZE 6 PS TRIATHLON BEADED FEMUR WAS PRESS-FIT INTO A PATIENT BUT THE CUTS MADE TO THE FEMUR BY THE MAKO WERE FOR A SIZE 5. THIS WAS NOT REALIZED UNTIL THE SURGEON VIEWED HIS POST OP FILMS AND SAW THE OBVIOUS CLEAR SPACE BETWEEN THE ANTERIOR FLANGE OF THE FEMORAL IMPLANT WITH THE ANTERIOR CONTEXT OF THE PATIENT¿S FEMUR. AT THE TIME THIS WAS BEING TYPED THE PLAN IS TO REVISE THE FEMUR AND POLY INSERT ON MARCH 4TH AT 6:30AM TO THE CORRECT SIZE 5 FEMORAL COMPONENT.

  Patient problems: Injury

  MAUDE report 9903784 ↗