Triathlon 5540-A-301Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327015058), received between Jul 25, 2019 and Jul 25, 2019 — 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.

• InjuryJul 25, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  POSTOPERATIVE DIAGNOSIS: THE PATIENT HAD A HISTORY OF LEFT KNEE REPLACEMENT (OUTSIDE OF CORS SCOPE). PATIENT UNDERWENT KNEE REVISION FOR MECHANICAL PROBLEM (B)(6)2017. THE PATELLA WAS RETAINED. THE PATIENT UNDERWENT LEFT KNEE REPLACEMENT REVISION OF FEMORAL COMPONENTS AND POLYETHYLENE (B)(6) 2019.

  Patient problems: Injury; Joint Laxity

  MAUDE report 8826036 ↗
• InjuryJul 25, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  POSTOPERATIVE DIAGNOSIS: THE PATIENT HAD A HISTORY OF LEFT KNEE REPLACEMENT (OUTSIDE OF CORS SCOPE). PATIENT UNDERWENT KNEE REVISION FOR MECHANICAL PROBLEM (B)(6) 2017. THE PATELLA WAS RETAINED. THE PATIENT UNDERWENT LEFT KNEE REPLACEMENT REVISION OF FEMORAL COMPONENTS AND POLYETHYLENE (B)(6) 2019.

  Patient problems: Injury; Joint Laxity

  MAUDE report 8825980 ↗