Triathlon 5537-G-611Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327027396), received between Jun 14, 2017 and Oct 23, 2020 — classified as 3 injuries, 1 malfunction.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 23, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED. AS REPORTED BY REP: "PATIENT DEVELOPED SCARRING THAT AFFECTED RANGE OF MOTION PER SURGEON. THINNER INSERT WAS IMPLANTED TO GIVE BETTER RANGE OF MOTION." SPOKE TO REP, WHO PROVIDED PRIMARY AND REVISION USAGE SHEETS AND AN X-RAY. NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Scar Tissue

  MAUDE report 10725216 ↗
• InjuryMay 21, 2019Unstable; Unstable

  PATIENT'S KNEE WAS REVISED FOR FLEXION INSTABILITY. THE FEMORAL COMPONENT AND TIBIAL INSERT WERE REVISED TO CORRECT THE ISSUE. LEFT KNEE.

  Patient problems: Injury

  MAUDE report 8627656 ↗
• MalfunctionJul 27, 2018Mechanical Problem; Mechanical Problem

  PRIMARY PROCEDURE, LEFT KNEE. IT WAS REPORTED THAT WHEN PRESSING IN THE TS INSERT USING THUMB PRESSURE AND FLEXING AND EXTENDING THE KNEE, THE WIRE HAD COME LOOSE. A SECOND IMPLANT WAS OPENED, USED, AND PERFORMED AS EXPECTED. A SURGICAL DELAY OF LESS THAN A MINUTE WAS REPORTED, UNKNOWN IF TOURNIQUET WAS USED. REP REPORTED THAT THE SURGEON WILL NOT RELEASE ANY ADDITIONAL INFORMATION AS NO PATIENT HARM WAS PERCEIVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7725701 ↗
• InjuryJun 14, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  SALES REP REPORTED A RIGHT KNEE REVISION SURGERY.

  Patient problems: Injury

  MAUDE report 6640516 ↗