Triathlon 5550-G-278Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613327014730), received between Oct 10, 2018 and Sep 20, 2021 — classified as 8 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjurySep 20, 2021Unstable; Unstable

  THIS PR WAS RAISED FROM A MEDICAL REVIEW FOR ANOTHER EVENT. THE PATIENT HAD LEFT KNEE ARTHROPLASTY ON (B)(6) 2011. A QUAD REPAIR WAS CARRIED OUT SIX MONTHS POST IMPLANTATION. REVISION SURGERY TOOK PLACE ON (B)(6) 2012 DUE TO INSTABILITY WHEREBY THE INSERT WAS REVISED. REVISION SURGERY TOOK PLACE ON (B)(6) 2016 DUE TO SUBSIDENCE AND INSTABILITY WHEREBY ALL COMPONENTS WERE REVISED.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 12496950 ↗
• InjurySep 4, 2019Crack; Crack

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO A CRACKED CR INSERT. PATIENT WAS REVISED TO A 13MM CS INSERT.

  Patient problems: Injury

  MAUDE report 8960487 ↗
• InjuryAug 9, 2019Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO FAILED RIGHT TOTAL KNEE ARTHROPLASTY, MECHANICAL LOOSENING OF COMPONENTS.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8879405 ↗
• InjuryJul 25, 2019Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "PAIN, GROSS INSTABILITY, MECHANICAL COMPLICATION AND SIGNIFICANT POLYETHYLENE WEAR AND DAMAGE OF LEFT TOTAL KNEE."

  Patient problems: Injury; Pain

  MAUDE report 8828102 ↗
• InjuryMay 20, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  KNEE REVISION (PATELLA ONLY). PATIENT HAD SYMPTOMS OF KNEE PAIN. SURGEON REMOVED SCAR TISSUE, AND REPLACED PATELLA.

  Patient problems: Injury; Pain; Scar Excision

  MAUDE report 8623883 ↗
• InjuryApr 4, 2019Unstable; Osseointegration Problem; Insufficient Device Problem Information; Unstable; Osseointegration Problem; Insufficient Device Problem Information

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

  Patient problems: Inadequate Osseointegration; Injury; Joint Laxity

  MAUDE report 8482471 ↗
• InjuryOct 10, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH MEDWATCH MW5079432 "TOTAL RIGHT HIP KNEE ARTHROPLASTY CAUSED DEBILITATION PAIN, STIFFNESS, RANGE OF MOTION LOSS REQUIRING 2009 MANIPULATION AND REVISION SURGERY ON 2013. MEDICAL DEVICE PARTS CAUSED METAL POISONING AND SEVERE ALLERGIES, REPEATED F/U OFFICE VISITS WITH SURGEON REPORTING PAIN, STIFFNESS, LOSS OF RANGE OF MOTION AND METAL POISONING . ATTENDED YEARS OF PHYSICAL THERAPY AND DAILY INTAKE OF PRESCRIPTION MEDICATION TO CONTROL SYMPTOMS. LENGTH OF TIME BETWEEN INITIAL SURGERY AND REVISION SURGERY CREATED DEBILITATING MEDICAL ISSUES AND PERMANENT DISABILITY. MANIPULATION SURGERY FOR ARTHROFIBROSIS ON 2009 AND METAL POISONING" THIS PI IS FOR REVISION SURGERY IN (B)(6) 2013.

  Patient problems: Ambulation or Postural Difficulties; Inflammation; Injury; Loss of Range of Motion; Pain; Reaction

  MAUDE report 7954219 ↗
• InjuryOct 10, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH MEDWATCH MW5079432, "TOTAL RIGHT HIP KNEE ARTHROPLASTY CAUSED DEBILITATION PAIN, STIFFNESS, RANGE OF MOTION LOSS REQUIRING 2009 MANIPULATION AND REVISION SURGERY ON 2013. MEDICAL DEVICE PARTS CAUSED METAL POISONING AND SEVERE ALLERGIES, REPEATED F/U OFFICE VISITS WITH SURGEON REPORTING PAIN, STIFFNESS, LOSS OF RANGE OF MOTION AND METAL POISONING. ATTENDED YEARS OF PHYSICAL THERAPY AND DAILY INTAKE OF PRESCRIPTION MEDICATION TO CONTROL SYMPTOMS. LENGTH OF TIME BETWEEN INITIAL SURGERY AND REVISION SURGERY CREATED DEBILITATING MEDICAL ISSUES AND PERMANENT DISABILITY. MANIPULATION SURGERY FOR ARTHROFIBROSIS ON 2009 AND METAL POISONING". THIS PI IS FOR MANIPULATION SURGERY FOR ARTHROFIBROSIS ON 2009.

  Patient problems: Ambulation or Postural Difficulties; Inflammation; Injury; Loss of Range of Motion; Pain; Reaction

  MAUDE report 7954020 ↗