Triathlon 5550-G-339Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07613327014754), received between Aug 21, 2018 and Sep 9, 2021 — classified as 10 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT; AFTER REVISION SURGERY, PATIENT STATES THAT HE CONTINUES TO EXPERIENCE PAIN AND SWELLING ON LEFT KNEE. PATIENT HAS HAD BONE SCANS AND IS CURRENTLY FOLLOWING UP WITH SURGEON AS HE STATES HIS KNEE FEELS LOOSE. *UPDATE ON 16-AUG-2021: THIS PI IS FOR THE SECOND REVISION ON (B)(6) 2013. PER MEDICAL REVIEW, "THE PATIENT UNDERWENT A SECOND REVISION ON (B)(6) 2013 WITH A DIAGNOSIS OF A PAINFUL UNSTABLE LEFT TOTAL KNEE ARTHROPLASTY. AT SURGERY THEY FOUND THAT THE FEMORAL COMPONENT WAS SLIGHTLY ELEVATED ANTERIORLY AND MAY HAVE RESULTED IN NARROWING THE PATELLOFEMORAL SPACE. THEY REMOVED THE FEMORAL COMPONENT THERE WAS SOME BONE LOSS LATERALLY AND ANTERIORLY AND POSTERIORLY, THEY FOUND ON THE MEDIAL SIDE THE POSTERIOR CONDYLE HAD NOT BEEN FULLY RESECTED AND THEY DOWNSIZED TO A SIZE 4. THE TIBIAL COMPONENT WAS ALSO LOOSE. THE PATELLA HAD A SCRATCH ON IT AND THEY REMOVED IT. THEY THEN CEMENTED A TRIATHLON SIZE 4 UNIVERSAL BASE PLATE AND CEMENTED A TRIATHLON X3 SYMMETRICAL 9 MM THICK PATELLA. THEY USED A SIZE 4 ¿ 16MM TOTAL STABILIZED POLY INSERT. "

  Patient problems: Osteolysis; Pain; Swelling/ Edema

  MAUDE report 12444876 ↗
• InjuryMar 8, 2021Break; Break

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO A FRACTURED PATELLAR COMPONENT. INTRA-OPERATIVELY, THE PEGS OF THE PATELLAR COMPONENT WERE FOUND TO HAVE BEEN SHEARED OFF. PATIENT DENIED ANY TRAUMA OR FALLS PRIOR TO SURGERY. THE PIECES OF THE PATELLAR COMPONENT WERE REMOVED AND REVISED, AND A 3X9 CR INSERT WAS REVISED BY A 3X13 CS INSERT TO INCREASE PATIENT STABILITY.

  Patient problems: Joint Laxity

  MAUDE report 11435347 ↗
• InjuryJun 18, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE SUBMISSION OF PRIMARY AND REVISION USAGE SHEET'S THAT THE PATIENT'S LEFT KNEE WAS REVISED. IN COMPARING THE SHEETS, A 6 X 9 CR INSERT WAS EXCHANGED FOR ANOTHER 6 X 9 CR INSERT. UPDATE: "REASON WAS INFECTION. NO FURTHER INFORMATION WILL BE GIVEN DUE TO HOSPITAL POLICY."

  Patient problems: Injury; Unspecified Infection

  MAUDE report 10166637 ↗
• InjuryJan 31, 2020Loss of Osseointegration; Loss of Osseointegration

  PROCEDURE: THE PATIENT UNDERWENT LEFT TOTAL KNEE REPLACEMENT 3/11/2016. PATIENT UNDERWENT LEFT TOTAL KNEE REVISION FOR MECHANICAL LOOSENING OF PATELLA IN 9/30/2019. LINER AND PATELLA EXCHANGED.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 9652530 ↗
• InjuryJun 11, 2019Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "MECHANICAL LOOSENING OF INTERNAL RIGHT KNEE PROSTHESIS".

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8687085 ↗
• InjuryMay 1, 2019Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "LAXITY TO RIGHT TOTAL KNEE." UPDATE ON 27-AUG-2021: THIS PI IS FOR REVISION SURGERY IN 2013. "[...] ON (B)(6) 2013 WITH A PREOPERATIVE DIAGNOSIS OF LAXITY TO RIGHT TOTAL KNEE. THE PROCEDURE WAS A REVISION OF THE POLYETHYLENE INSERT. SURGEON REMOVED THE 9 MM INSERT AND PUT IN AN 11 MM. "

  Patient problems: Injury; Joint Laxity; Pain

  MAUDE report 8568701 ↗
• InjuryApr 11, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO: "1. HISTORY OF LEFT TOTAL KNEE ARTHROPLASTY 18 MONTHS AGO. 2. CHRONIC PAIN ABOUT THE PROXIMAL LEFT TIBIA WITH CONCERN FOR ASEPTIC LOOSENING OF THE TIBIAL COMPONENT. 3. GROSSLY LOOSE TIBIAL COMPONENT. 4. PROC REVISION LT TOTAL KNEE, TIBIAL COMPONENT ONLY".

  Patient problems: Injury

  MAUDE report 8504159 ↗
• 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 ALLEGEDLY THE PATIENT WAS REVISED DUE TO "PAINFUL LEFT TOTAL KNEE ARTHROPLASTY WITH ADHESIONS AND MILD SIDE-TO-SIDE LAXITY."

  Patient problems: Inadequate Osseointegration; Injury; Pain

  MAUDE report 8466723 ↗
• InjuryFeb 22, 2019Unstable; Unstable

  POSTOPERATIVE DIAGNOSIS: PATIENT UNDERWENT PRIMARY RIGHT KNEE REPLACEMENT (B)(6) 2018. PATIENT RETURNED TO UNDERGO THE REVISION DUE TO PATELLAR INSTABILITY AND PAIN ON (B)(6) 2018 WITH A HINGE PROSTHESIS. ALL COMPONENTS EXCHANGED.

  Patient problems: Injury; Pain

  MAUDE report 8361899 ↗
• InjuryAug 21, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  REVISED TOTAL KNEE FOR INFECTION AND LOOSE COMPONENTS. TIBIA AND FEMUR WERE LOOSE. INFECTION REPORTED BY SURGEON, UNKNOWN IF CLINICALLY CONFIRMED OR IDENTIFIED.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7802663 ↗