Triathlon 5532-G-319Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327050660), received between Dec 12, 2017 and Jun 17, 2020 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 17, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IN RESPONSE TO FOLLOW-UP, AN EXAM NOTE FROM (B)(6) 2020 NOTED: "...SHE EXPERIENCES MILD DISCOMFORT AT THE LATERAL JOINT LINE AND INTO THE DISTAL IT BAND...SHE IS ABLE TO WALK COMFORTABLY BUT STRUGGLES AS THE DISTANCE BECOMES GREATER..." THE REPORTED TREATMENT PLAN INCLUDES FORMAL PHYSICAL THERAPY.

  Patient problems: Discomfort

  MAUDE report 10161522 ↗
• InjuryDec 12, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  SECOND WASHOUT AND POLY REPLACEMENT OF INFECTED RIGHT KNEE WAS PERFORMED. SURGEON STATED STAPH EPI IS THE INFECTING MICROORGANISM. NOTHING WAS LOOSE OR BROKEN.

  Patient problems: Bacterial Infection; Injury

  MAUDE report 7110834 ↗