Triathlon 5526-B-300Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327041347), received between Feb 1, 2018 and May 22, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Malposition of Device” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 22, 2026Fracture

  THE FOLLOWING INFORMATION WAS PROVIDED: A PIECE OF THE POSTERIOR PART OF A TRIATHLON BASEPLATE HAS BROKEN OFF INSIDE THE PATIENT.¿ INSTABILITY AND PAIN IN THE PATIENT.

  Patient problems: Insufficient Information; Joint Laxity; Pain

  MAUDE report 25260173 ↗
• InjuryApr 24, 2023Malposition of Device; Malposition of Device

  KNEE REVISION. REASON FOR REVISION: INSTABILITY. UPDATE - IN THIS PARTICULAR CASE THE FEMORAL COMPONENT WAS PLACED POSTERIOR TO ITS IDEAL POSITION AND THE TIBIAL IMPLANT WAS PLACED IN A GREATER DEGREE OF FLEXION THAN IDEAL.

  Patient problems: Joint Laxity

  MAUDE report 16793261 ↗
• InjuryAug 22, 2018Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem

  KNEE REVISION DUE TO INSTABILITY. UPDATE BASED ON MEDICAL REVIEW: BASEPLATE MALPOSITION IN EXCESSIVE POSTERIOR TIBIAL SLOPE AND EXCESSIVE PROXIMAL TIBIAL BONE REMOVAL HAVE RENDERED THE PCL DYSFUNCTIONAL WITH SEVERE INSTABILITY.

  Patient problems: Injury

  MAUDE report 7805553 ↗
• InjuryFeb 1, 2018Malposition of Device; Positioning Problem; Malposition of Device; Positioning Problem

  THE SURGEON REPORTED VIA THE SALES REP, PER-OLAF BRETTMAR THAT A FEMALE PATIENT UNDERWENT A REVISION OF THE LEFT KNEE ON (B)(6) 2017 DUE TO A FRACTURED TIBIAL INSERT SIZE 3 9MM. IT WAS FURTHER REPORTED THAT THE PATIENT HAD EXPERIENCED A TWISTING TRAUMA TO THE KNEE APPROXIMATELY 2 MONTHS PRIOR TO THE REVISION. IT WAS FURTHER REPORTED THAT THE OPERATION BEGAN AS AN EXPLORATORY ENDOSCOPY BUT WAS TRANSFERRED TO AN OPEN PROCEDURE WHEN IT WAS DISCOVERED THAT THE INSERT HAD FRACTURED. IT WAS FURTHER REPORTED THAT THE INSERT WAS REPLACED WITH A SIZE 3 11MM INSERT AND THAT THE PRIMARY OPERATION TOOK PLACE ON (B)(6) 2016. UPDATE: THE MEDICAL REVIEW CONCLUDED MALPOSITION OF BOTH THE FEMORAL COMPONENT AND THE BASEPLATE.

  Patient problems: Injury

  MAUDE report 7233636 ↗