Triathlon 5520-M-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327041125), received between Sep 18, 2018 and Nov 6, 2020 — classified as 3 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 6, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED BY THE PATIENT'S ATTORNEY AS A RESULT OF A LEGAL CLAIM THAT ALLEGEDLY ON (B)(6) 2014 THE PATIENT UNDERWENT A LEFT SIDED TOTAL KNEE ARTHROPLASTY USING SIMPLEX HV BONE CEMENT AND TRIATHLON KNEE SYSTEM. IT IS FURTHER ALLEGED THAT ON (B)(6) 2016 HE HAD TO UNDERGO A REVISION SURGERY DUE TO ASEPTIC LOOSENING OF THE TIBIAL COMPONENT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 10799782 ↗
• InjuryMar 29, 2019Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN WHEN WALKING AFTER SURGERY. PATIENT STATES KNEE WAS LOOSE AND THEREFORE REQUIRED A REVISION SURGERY IN (B)(6) 2011. UPDATE: IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO "PAINFUL LEFT TOTAL KNEE ARTHROPLASTY WITH ADHESIONS AND MILD SIDE-TO-SIDE LAXITY."

  Patient problems: Ambulation or Postural Difficulties; Inadequate Osseointegration; Injury; Pain

  MAUDE report 8466722 ↗
• InjurySep 18, 2018Osseointegration Problem; Osseointegration Problem

  PATIENT HAD HIS KNEE REVISED FOR LAXITY AND PATELLA LOOSENING. THE EXPLANTED PATELLA WAS MISSING ITS PEGS AND THERE WAS NO CEMENT ATTACHED TO THE IMPLANT. THERE WERE CHUNKS OF COBALT CEMENT IN THE JOINT SPACE. THE TIBIAL COMPONENT WAS REMOVED AND REPLACED WITH A UNIVERSAL BASEPLATE AND TS POLY INSERT. THE PS FEMORAL COMPONENT WAS RETAINED. THE PATELLA WAS RESECTED AGAIN AND REPLACED WITH A 36MM X3 SYMMETRIC PATELLA. UPDATE 11-SEP-2018: IT WAS REPORTED THROUGH MEDWACTH MW5079401 "THE PT HAD A KNEE REPLACEMENT ON 2013. HE HAD A REVISION SURGERY ON 2018 WHERE IT WAS DISCOVERED THE PATELLA BUTTON HAD FRACTURED AT ITS PEGS. THE VENDOR REP WAS IN THE REVISION SURGERY."

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 7884621 ↗