Triathlon 5537-G-216Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327027068), received between Apr 11, 2018 and May 7, 2024 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 7, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO EXTENSION MECHANISM DISRUPTION. A 2X16 TS INSERT WAS REVISED TO A 2X13 TS INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Loss of Range of Motion

  MAUDE report 19257841 ↗
• InjuryNov 15, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDICAL RECORDS PROVIDED FOR LEGAL PI HAVE INDICATED ADDITIONAL TREATMENTS/REVISIONS THE PATIENT UNDERWENT. THIS PI IS FOR A REVISION SURGERY THE PATIENT UNDERWENT ON (B)(6)2017 . IT IS NOTED THAT THE REVISION SURGERY WAS OF COMPETITOR DEVICES, HOWEVER, THE EXISTENCE OF INFECTION OF THE WOUND AROUND THE SCREW (MRSA) IS REPORTED. EXCERPT FROM MEDICAL REVIEW: "WITH LOCAL PERSISTENT PAIN AROUND THE TIBIAL TUBERCLE SCREW, IT WAS DECIDED TO REMOVE THIS SCREW AND AS SUCH WAS PERFORMED ON (B)(6)2017 . BACTERIAL CULTURES OF THE WOUND AROUND THE SCREW DID RESULT IN CULTURE OF METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS (MRSA)."

  Patient problems: Bacterial Infection; Injury; Pain; Unspecified Infection

  MAUDE report 9328746 ↗
• InjuryApr 11, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT CONTINUED TO PRESENT WITH PAIN AND SYMPTOMS OF INFECTION HAD AN I&D ON (B)(6) 2017.

  Patient problems: Injury; Pain; Unspecified Infection

  MAUDE report 7422284 ↗