Triathlon 5556-L-360Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327013511), received between May 14, 2021 and Oct 11, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Insert” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 11, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO PAIN AND INSTABILITY. INTRA-OPERATIVELY, DAMAGE TO THE PATELLAR COMPONENT WAS NOTED (REPORTED AS 'MORE LIKE NOTCHING, LIKE IT WAS HITTING SOMETHING, THAN WEAR'). THE PATELLAR COMPONENT AND INSERT WERE REVISED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity; Pain

  MAUDE report 17911144 ↗
• MalfunctionMay 14, 2021Difficult to Insert; Difficult to Insert

  TRIATHLON TRITANIUM PATELLA NOT ABLE TO BE FULLY SEATED. MULTIPLE ATTEMPTS TO FULLY SEAT INCLUDING USING PRESS-FIT CLAMP AND BUTTON WITHOUT SUCCESS. MEDIAL POST SITTING UP AND PREVENTING THE PATELLA FROM SITTING DOWN NICELY. THE SURGEON ENDED UP HAVING TO CEMENT A PATELLA RATHER THAN PRESS FIT. SURGICAL DELAY: = 15 MINUTES. CASE TYPE / APPLICATION: TKA. UPDATE: DRILLS AND TEMPLATES USED: MB DRILL BIT WITH SYMMETRIC 36 PATELLA TEMPLATE. PATIENT BONE QUALITY: VERY SCLEROTIC, HARD BONE CLAMP USED: TRITANIUM PATELLA CLAMP WITH SYMMETRIC 36 PATELLA BUTTON FOLLOWED BY WHITE TIP PATELLA CLAMP ATTACHMENT ON TEMPLATE/CLAMP HANDLE AS WELL AS THE CIRCULAR CLAMP ATTACHMENT. PATELLA IMPLANTED: THE PATELLA IN QUESTION WAS NOT IMPLANTED. AFTER UNSUCCESSFULLY BEING SEATED, TRITANIUM PATELLA WAS REMOVED AND A SYMMETRIC CEMENTED PATELLA WAS IMPLANTED. THE UNSUCCESSFULLY IMPLANTED PATELLA IS NOW AVAILABLE FOR RETURN.

  Patient problems: Insufficient Information

  MAUDE report 11826892 ↗