Triathlon 5550-G-391Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327014785), received between May 1, 2019 and Sep 18, 2023 — classified as 7 injuries.

The most frequently reported specific device problem is “Fracture” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2023Degraded; Naturally Worn; Degraded; Naturally Worn

  DURING A KNEE REVISION, THE SURGEON NOTICED A HORIZONTAL LINE/GROOVE ON THE MEDIAL SIDE OF A #6 LEFT CR CEMENTED FEMORAL COMPONENT. THE SURGEON ALSO NOTICED EXTREME WEAR ON THE MEDIAL SIDE OF A#6 9MM CS POLY INSERT AND WEAR ON THE SYMMETRICAL 39X11MM PATELLA. WHILE REMOVING THE LEFT FEMORAL COMPONENT FROM THE PT¿S FEMUR, THE SURGEON WAS ABLE TO REMOVE THE BROKEN FEMORAL SECTION OF THE COMPONENT. FEMORAL COMPONENT, TIBIAL POLY INSERT AND THE PATELLA WERE REPLACED.

  Patient problems: Insufficient Information

  MAUDE report 17762842 ↗
• InjuryNov 8, 2021Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INSTABILITY AND A CYST FORMING UNDER THE PATELLAR COMPONENT. THE PATIENT WAS REVISED FROM AN 8X11 PS INSERT TO AN 8X11 TS INSERT AND THE 39MM SYMMETRIC PATELLA WAS SWAPPED FOR ANOTHER OF THE SAME SIZE. ASIDE FROM THE PROVIDED PRIMARY USAGE SHEET, REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Cyst(s); Joint Laxity

  MAUDE report 12775199 ↗
• InjuryAug 18, 2021Fracture; Migration; Fracture; Migration

  THE FOLLOWING WAS REPORTED THAT: "3 SHEARED PATELLAR BLOCKS, MIGRATION OF THE PATELLA INTO THE FEMUR, PAIN". PATIENT REQUIRED REVISION SURGERY ON THE (B)(6) 2021.

  Patient problems: Pain

  MAUDE report 12336357 ↗
• InjuryJul 24, 2019Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  POSTOPERATIVE DIAGNOSIS: PATIENT UNDERWENT LEFT TOTAL KNEE REPLACEMENT (B)(6) 2015. THE PATELLAR COMPONENT FRACTURED ACROSS THE PEGS. THE PATELLAR COMPONENT WAS LOOSE AND REMOVED. PATIENT UNDERWENT REVISION OF THE LINER ALSO ON (B)(6) 2019.

  Patient problems: Injury

  MAUDE report 8821681 ↗
• InjuryJul 2, 2019Unstable; Unstable

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO" ONE YEAR STATUS POST CEMENTLESS LEFT TOTAL KNEE ARTHROPLASTY WITH ANTERIOR-POSTERIOR INSTABILITY."

  Patient problems: Injury

  MAUDE report 8754456 ↗
• InjuryJun 21, 2019Osseointegration Problem; Osseointegration Problem

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

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8721888 ↗
• InjuryMay 1, 2019Osseointegration Problem; Osseointegration Problem

  POSTOPERATIVE DIAGNOSIS: THE PATIENT UNDERWENT LEFT TOTAL KNEE ARTHROPLASTY (B)(6) 2015. PATIENT HAD MECHANICAL COMPLICATION WITH LOOSE PATELLA POLYETHYLENE INPLANT, THE PATELLAR COMPONENT WAS REMOVED AND THE LINER WAS EXCHANGED (B)(6) 2018.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8568467 ↗