Triathlon 5540-A-202Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327015034), received between Dec 2, 2021 and Dec 2, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2021Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  IT WAS REPORTED BY STRYKER SALE REP THAT DURING THE REVISION SURGERY, THE AUGMENT (5540-A-202) (TRIATHLON FEMORAL DISTAL AUGMENT-RIGHT) (LOT NO BDS4D) WAS BULGED OUT AT TRIATHLON TS FEMORAL COMPONENT LEFT (5512-F-201) (LOT NO BII3R). SURGEON HAS REQUESTED TO USE SIZE 1 FEMORAL DISTAL AUGMENT-RIGHT (5540-A-102) (LOT NO BIR3B). PATIENT IS UNDERGOING REVISION SURGERY DUE TO POST INFECTED KNEE. PATIENT WAS ON CEMENT SPACER UPDATE: STRYKER SALES CONFIRMED THAT THE REVISION SURGERY COMPLETED ON (B)(6). IS THE SECOND REVISION SURGERY. THE FIRST REVISION SURGERY IS USING NON-STRYKER IMPLANT (CEMENT SPACER) AND THE DATE IS UNKNOWN. SALES ALSO DO NOT HAVE THE INFORMATION ON THE PRIMARY SURGERY (EG: DATE). UPDATE 2 : THIS PI IS SUBMITTED FOR IMPLANT FOUND OUT HAVING ISSUE DURING THE SURGERY ON (B)(6) 2021. THE IMPLANT WAS FOUND BULGED OUT WHEN SALES REP WAS INSTALLING TO THE FEMORAL COMPONENT BEFORE SURGEON IMPLANTING INTO PATIENT BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12914973 ↗