Triathlon 5531-P-609Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613327042399), received between Oct 12, 2018 and Oct 21, 2025 — classified as 9 injuries.

The most frequently reported specific device problem is “Unstable” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT IS STATUS POST REVISION RTKA COMPLETED TODAY DUE TO INFECTION. NO ADDITIONAL DETAILS TO BE REPORTED BY FACILITY.

  Patient problems: Unspecified Infection

  MAUDE report 23348478 ↗
• InjuryJan 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT STATUS POST RIGHT KNEE POLY EXCHANGE DUE TO INFECTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 21199663 ↗
• InjuryDec 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RIGHT TOTAL KNEE. THE REVISION TODAY WAS SECONDARY TO PAIN, SWELLING AND BLOOD IN THE KNEE DISCOVERED UPON ASPIRATION. THE KNEE WAS OPENED UP, WASHED OUT, AND ELECTROCAUTERY WAS USED TO STOP BLEEDING WITHIN THE JOINT. A NEW INSERT WAS PLACED. NO FURTHER INFORMATION AVAILABLE FROM HOSPITAL OR SURGEON.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 18316654 ↗
• InjuryJun 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LEFT KNEE STIFFNESS, STATUS POST KNEE REPLACEMENT. PROCEDURES TO TREAT THIS DIAGNOSIS WERE 1. LYSIS OF ADHESIONS AND 2. MANIPULATION UNDER ANESTHESIA, BOTH ON (B)(6)2018.

  Patient problems: Loss of Range of Motion; Scar Tissue

  MAUDE report 17241103 ↗
• InjuryDec 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: REVISION WAS PERFORMED DUE TO PATELLO-FEMORAL PAIN. THE PATELLA WAS RESURFACED AND THE INSERT WAS EXCHANGED TO FACILITATE A THOROUGH WASHOUT OF THE JOINT. THE USE OF THE MAKO IN THE INDEX PROCEDURE WAS NOT MENTIONED AS HAVING ANY RELEVANCE TO THE PATELLO-FEMORAL PAIN. NO OTHER INFORMATION IS AVAILABLE FROM THE DOCTOR OR HOSPITAL.

  Patient problems: Pain

  MAUDE report 16002682 ↗
• InjurySep 19, 2022Unstable; Unstable

  PATIENT REPORTED PRIMARY RIGHT KNEE IMPLANT ON (B)(6) 2021 AND REPORTED ONGOING PAIN AND INSTABILITY. PATIENT WOULD LIKE TO KNOW IF PARTS ARE SUBJECT TO A RECALL.

  Patient problems: Pain

  MAUDE report 15451616 ↗
• InjuryOct 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT'S LEFT KNEE WAS REVISED DUE TO INFECTION. REP PROVIDED PRIMARY AND REVISION USAGE SHEET'S AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 12708586 ↗
• InjuryAug 3, 2021Unstable; Unstable

  AS REPORTED: "THE (RIGHT KNEE) REVISION WAS PERFORMED DUE TO FLEXION INSTABILITY. THERE IS NO FURTHER INFORMATION AVAILABLE." SPOKE TO REP, WHO PROVIDED THE PRIMARY MAKO AND REVISION USAGE SHEETS. THERE ARE NO ALLEGATIONS AGAINST ANY OF THE BONE CUTS OR IMPLANT POSITIONING. A CR FEMUR, CS INSERT, AND CEMENTED PATELLA WERE REVISED TO A PS FEMUR WITH AUGMENTS, A TS INSERT, AND ANOTHER CEMENTED PATELLA. REP RE-CONFIRMED NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity

  MAUDE report 12271595 ↗
• InjuryOct 12, 2018Break; Crack; Fracture; Break; Crack; Fracture

  KNEE SCOPE FOR CLEAN OUT BUT WENT TO POLY EXCHANGE BECAUSE THE N2VAC POLY HAD FRACTURED ON THE POSTEROMEDIAL ASPECT. UPDATE 30-SEPTEMBER-2018: AS REPORTED: "SCHEDULED KNEE SCOPE FOR LOOSE BODY TURNED TO A POLY EXCHANGE FOR A SIZE 6 9 MM TIBIAL BEARING INSERT, N2VAC CS. UPPED THE POLY SIZE TO 11MM, SAME TYPE OF IMPLANT. THE POLY FRACTURED ON THE POSTEROMEDIAL ASPECT OF THE INSERT. CAUSE FOR FRACTURE UNKNOWN TO REP AND SURGEON".

  Patient problems: Injury

  MAUDE report 7960919 ↗